By Rep. Mike Honda (D-Calif.) - 06/18/10 09:05 AM ET
At a Government and Oversight Reform Committee hearing this week, I testified to the devastating and deadly impacts of an unsuspecting disease: Viral Hepatitis. The fact that I was joined by Dr. Howard Koh, Assistant Secretary for Health, and Dr. John Ward, Director of the Viral Hepatitis Program at the Center for Disease Control, underscores the importance of the issue. Government oversight is a good start to getting the American public more informed, but much more is needed, according to the Institute of Medicine's 2010 report titled "Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C".
Few realize how highly infectious viral hepatitis is. Hepatitis B is 100 times more infectious than HIV. Few realize that, left untreated, it can cause liver disease, liver cancer, and premature death decades after infection. Few realize that roughly 2 billion people worldwide have been infected with Hepatitis B; over 170 million people are chronically infected with Hepatitis C; and in this nation alone, an estimated 5.3 million people are infected with either Hepatitis B or Hepatitis C. Tragically, an average of two-thirds of those infected are unaware of their status.
It is no surprise, then, that some are calling this a silent crisis. However, we cannot afford to be silent anymore. In fact, we will not be silent any more. Why? Because our countrymen and women are dying daily, needlessly, from a disease that is entirely preventable if detected early. Each year, approximately 15,000 people die from liver cancer or liver diseases related to Hepatitis B and Hepatitis C. That's over 40 Americans dying every day, with no state or district in our nation exempt from its deadly reach.
Beyond the tragic and preventable loss of human life and its subsequent hit to our country's productivity, the costs to our country our explicitly economic as well. Without effective prevention and vaccination methods in place, chronic Hepatitis B and C is expected to cost our country at least $20 billion, in treatments alone, over the next 10 years. As a result, over the same time frame, commercial and Medicare costs will more than double. Projecting further out, over the next 20 years, total medical costs for patients with Hepatitis C infection are expected to increase more than 2.5 times from $30 billion to over $85 billion.
We must, therefore, change the way Hepatitis is diagnosed and treated. With the help of Chairman Towns and Reps Cassidy, Johnson, and Dent, I introduced the Viral Hepatitis and Liver Cancer Control and Prevention Act, H.R. 3974, which provides nearly $600 million over the next five years to treat hepatitis. Our legislation focuses federal efforts on a strategy that saves lives and makes our health system more efficient. We bring together the common concerns of the diverse viral hepatitis community to fight chronic viral hepatitis by establishing, promoting, and supporting a comprehensive prevention, research and medical management referral program. And we strengthen the ability of the Center for Disease Control to support state health departments in the prevention, immunization and surveillance efforts.
Through this legislation, and with strategic investments in public health and prevention program, billions of dollars can be saved, so too the lives of tens of thousands of people in states and cities all over American. I urge all of you to join me in supporting activities that promote early detection and education. With your help, we can sound the alarm on this silent crisis.
Source:
http://thehill.com/blogs/congress-blog/healthcare/104081-we-will-not-be-silent-on-viral-hepatitis-rep-mike-honda
June 17, 2010
NVHR Launches Targeted Print Advertising Campaign Urging Swift Congressional Action on Secret Epidem
As Congress prepares to shine a spotlight this week on chronic viral hepatitis, the National Viral Hepatitis Roundtable (NVHR) today launched a new targeted print advertising campaign to urge swift action on bipartisan legislation providing federal funding for state-based screening and early intervention programs. NVHR's new advertising initiative comes in advance of a hearing Thursday, June 17, before the full House Oversight & Government Reform Committee, chaired by Chairman Ed Towns (D-NY) and Ranking Member Darrell Issa (R-Calif.). The Committee has invited testimony from a diverse panel of witnesses who will offer strategies for implementing expert recommendations made earlier this year by the Institute of Medicine (IOM).
NVHR is a coalition of more than 175 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. http://www.nvhr.org/
"NVHR's new advertising initiative is a timely reminder to Congress, the Administration, and all stakeholders that federal action is desperately needed this year to help combat this insidious disease that affects over 5 million Americans and their loved ones," said Ms. Lorren Sandt, Chair of the National Viral Hepatitis Roundtable (NVHR) and Executive Director of Caring Ambassadors Program, based in Portland, OR. "Six months ago, the Institute of Medicine issued nearly two-dozen expert recommendations for improving the federal government's response to the viral hepatitis epidemic. The pressing challenge now before Congress and the Administration is to provide federal funding to translate the IOM report into swift and decisive action."
Under the banner of "Mission: Possible," NVHR's new advertisement highlights the IOM report and urges action on HR 3974. The advertisement also features the tagline "If Congress gets on the case now, the leading cause of liver cancer won't stand a chance."
Thursday's hearing before the House Oversight & Government Reform Committee is an important step forward in this fight. An estimated 5.3 million Americans have been infected with chronic viral hepatitis B or C - and with most unaware of their infection, millions are at risk of developing life-threatening complications, especially African Americans and Asian Americans. Without detection and treatment, chronic viral hepatitis leads to liver cancer, cirrhosis, or liver failure. In the absence of federal leadership, the research firm Milliman estimates that public and private payers' cost of treating chronic viral hepatitis C alone will more than triple by 2024 to $85 billion annually. Medicare and Medicaid would absorb a disproportionate share of these added costs.
HR 3974, "The Viral Hepatitis and Liver Cancer Control and Prevention Act," is sponsored by Representatives Mike Honda (D-Calif.), Charles Dent (R-Pa.) and 49 other House Members and would help turn the tide. The Honda-Dent legislation would increase the ability of the CDC to support state health departments in their prevention, immunization and surveillance, and referral to care efforts. Much of the Honda-Dent legislation tracks with the IOM's recommendations.
Source: National Viral Hepatitis Roundtable
Source
NVHR is a coalition of more than 175 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. http://www.nvhr.org/
"NVHR's new advertising initiative is a timely reminder to Congress, the Administration, and all stakeholders that federal action is desperately needed this year to help combat this insidious disease that affects over 5 million Americans and their loved ones," said Ms. Lorren Sandt, Chair of the National Viral Hepatitis Roundtable (NVHR) and Executive Director of Caring Ambassadors Program, based in Portland, OR. "Six months ago, the Institute of Medicine issued nearly two-dozen expert recommendations for improving the federal government's response to the viral hepatitis epidemic. The pressing challenge now before Congress and the Administration is to provide federal funding to translate the IOM report into swift and decisive action."
Under the banner of "Mission: Possible," NVHR's new advertisement highlights the IOM report and urges action on HR 3974. The advertisement also features the tagline "If Congress gets on the case now, the leading cause of liver cancer won't stand a chance."
Thursday's hearing before the House Oversight & Government Reform Committee is an important step forward in this fight. An estimated 5.3 million Americans have been infected with chronic viral hepatitis B or C - and with most unaware of their infection, millions are at risk of developing life-threatening complications, especially African Americans and Asian Americans. Without detection and treatment, chronic viral hepatitis leads to liver cancer, cirrhosis, or liver failure. In the absence of federal leadership, the research firm Milliman estimates that public and private payers' cost of treating chronic viral hepatitis C alone will more than triple by 2024 to $85 billion annually. Medicare and Medicaid would absorb a disproportionate share of these added costs.
HR 3974, "The Viral Hepatitis and Liver Cancer Control and Prevention Act," is sponsored by Representatives Mike Honda (D-Calif.), Charles Dent (R-Pa.) and 49 other House Members and would help turn the tide. The Honda-Dent legislation would increase the ability of the CDC to support state health departments in their prevention, immunization and surveillance, and referral to care efforts. Much of the Honda-Dent legislation tracks with the IOM's recommendations.
Source: National Viral Hepatitis Roundtable
Source
A nutritional supplement for treating chronic hepatitis C: Viusid
Contact: Ye-Ru Wang
wjg@wjgnet.com
86-105-908-0039
World Journal of Gastroenterology
The pathogenesis of chronic hepatitis C (CHC) is associated with severe oxidative stress and non-selective immunological disturbance that lead to necroinflammation and the progression of fibrosis. Several trials have suggested that antioxidant and immunostimulant therapies may have a beneficial effect. Two previous clinical studies have reported that the Viusid related effect on histologic features, especially fibrosis, appears to be associated with antioxidant and/or immunomodulatory properties. However, the putative mechanism of action of Viusid is unknown.
A research article to be published on June 7, 2010 in the World Journal of Gastroenterology addresses this question. The authors reported the results of a randomized double-blind and placebo-controlled study to evaluate the effect of Viusid on oxidative stress and cytokine parameters in patients with CHC who had been nonresponders to previous antiviral therapy with peginterferon plus ribavirin and infected with genotype 1.
Their results show that Viusid improves oxidative stress through reduction of lipid peroxidation products and has an immunomodulatory effect on cytokine secretion via increased production of IFN-γ and IL-10, decreased production of IL-1α, and stabilized TNF-α secretion in patients with CHC who have failed previous antiviral treatment. Thus, Viusid is an interesting strategy of treatment for those patients who don't eradicate their viral infection or when antiviral treatment is contraindicated (decompensated cirrhosis). The administration of Viusid was well tolerated. Further studies are needed to evaluate the clinical impact of the administration of Viusid in patients with end-stage liver disease secondary to CHC.
###
Reference: Gomez EV, Perez YM, Sanchez HV, Forment GR, Soler EA, Bertot LC, Garcia AY, del Rosario Abreu Vazquez M, Fabian LG. Antioxidant and immunomodulatory effects of Viusid in patients with chronic hepatitis C. World J Gastroenterol 2010; 16(21): 2638-2647 http://www.wjgnet.com/1007-9327/full/v16/i21/2638.htm
Correspondence to: Dr. Eduardo Vilar Gomez, PhD, Associated Professor, Department of Hepatology, National Institute of Gastroenterology, 25th Avenue, 503, Vedado, Havana 10400, Cuba. vilar@infomed.sld.cu
Telephone: +53-7-8325067 Fax: +53-7-8333253
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection and provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2008 IF: 2.081. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
http://www.eurekalert.org/pub_releases/2010-06/wjog-ans061710.php
wjg@wjgnet.com
86-105-908-0039
World Journal of Gastroenterology
The pathogenesis of chronic hepatitis C (CHC) is associated with severe oxidative stress and non-selective immunological disturbance that lead to necroinflammation and the progression of fibrosis. Several trials have suggested that antioxidant and immunostimulant therapies may have a beneficial effect. Two previous clinical studies have reported that the Viusid related effect on histologic features, especially fibrosis, appears to be associated with antioxidant and/or immunomodulatory properties. However, the putative mechanism of action of Viusid is unknown.
A research article to be published on June 7, 2010 in the World Journal of Gastroenterology addresses this question. The authors reported the results of a randomized double-blind and placebo-controlled study to evaluate the effect of Viusid on oxidative stress and cytokine parameters in patients with CHC who had been nonresponders to previous antiviral therapy with peginterferon plus ribavirin and infected with genotype 1.
Their results show that Viusid improves oxidative stress through reduction of lipid peroxidation products and has an immunomodulatory effect on cytokine secretion via increased production of IFN-γ and IL-10, decreased production of IL-1α, and stabilized TNF-α secretion in patients with CHC who have failed previous antiviral treatment. Thus, Viusid is an interesting strategy of treatment for those patients who don't eradicate their viral infection or when antiviral treatment is contraindicated (decompensated cirrhosis). The administration of Viusid was well tolerated. Further studies are needed to evaluate the clinical impact of the administration of Viusid in patients with end-stage liver disease secondary to CHC.
###
Reference: Gomez EV, Perez YM, Sanchez HV, Forment GR, Soler EA, Bertot LC, Garcia AY, del Rosario Abreu Vazquez M, Fabian LG. Antioxidant and immunomodulatory effects of Viusid in patients with chronic hepatitis C. World J Gastroenterol 2010; 16(21): 2638-2647 http://www.wjgnet.com/1007-9327/full/v16/i21/2638.htm
Correspondence to: Dr. Eduardo Vilar Gomez, PhD, Associated Professor, Department of Hepatology, National Institute of Gastroenterology, 25th Avenue, 503, Vedado, Havana 10400, Cuba. vilar@infomed.sld.cu
Telephone: +53-7-8325067 Fax: +53-7-8333253
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection and provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2008 IF: 2.081. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
http://www.eurekalert.org/pub_releases/2010-06/wjog-ans061710.php
One Year After the Launch of Telaprevir and Boceprevir, Surveyed Physicians Expect to Prescribe Triple Therapy Regimens to 90 Percent of Their Hepatitis C Virus Patients
press release
June 17, 2010, 9:00 a.m. EDT
Twenty-Five Percent of Surveyed MCOs Expect to Add Both Telaprevir and Boceprevir to Their Formularies, According to a New Report from Decision Resources
WALTHAM, Mass., June 17, 2010 /PRNewswire via COMTEX/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, based on clinical profiles provided to them, surveyed clinicians estimate that one year after the launch of Vertex Pharmaceuticals/Johnson & Johnson/Mitsubishi Tanabe Pharma's telaprevir and Merck's boceprevir, at least 90 percent of hepatitis C virus (HCV) patients will be treated with triple therapy regimens.
The new Physician & Payer Forum report entitled Hepatitis C: Reimbursement and Uptake of Novel Antivirals Among Payers and Prescribers finds that surveyed physicians expect to treat 71 percent of treatment-naive and 78 percent of nonresponder patients with telaprevir/peg-IFN/ribavirin and 19 percent of treatment-naive and nonresponders with boceprevir/peg-IFN/ribavirin. Similar to clinicians, managed care organizations' (MCO) pharmacy directors are open to reimbursing telaprevir and boceprevir. However, surveyed pharmacy directors do not indicate a clear preference for either one of these protease inhibitors.
"Only 10 percent of the pharmacy directors we surveyed do not expect to add telaprevir or boceprevir to their drug formularies," said Decision Resources Analyst Alexandra Makarova, M.D. Ph.D. "The remaining surveyed pharmacy directors are split regarding the choice of the protease inhibitor for addition to their formularies. Twenty-five percent expect to add both telaprevir and boceprevir, while 15 percent will add only telaprevir and 5 percent will add only boceprevir. Forty percent of pharmacy directors will make their choice based on the relative cost of each agent."
The report also finds that almost half of surveyed clinicians indicate that they will use Roche's Pegasys and Merck's PegIntron interchangeably in combination with an HCV-specific antiviral agent even if this agent was evaluated in clinical trials involving only one of these peg-IFNs. However, one-third of doctors expect to combine a novel HCV-specific antiviral agent only with the peg-IFN that was used with the antiviral agent in clinical trials. These physicians indicate that they will likely use Pegasys in triple therapy regimens as the majority of HCV-specific antiviral agents are being evaluated with Pegasys rather than PegIntron.
Hepatitis C: Reimbursement and Uptake of Novel Antivirals Among Payers and Prescribers is based on a U.S. survey of 74 gastroenterologists, 26 hepatologists and 20 MCO pharmacy directors. Their responses were compared to assess similarities and differences of opinion regarding clinical, economic and scientific factors.
About Decision Resources
Decision Resources (www.decisionresources.com ) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com .
All company, brand, or product names contained in this document may be trademarks or
registered trademarks of their respective holders.
http://www.marketwatch.com/story/one-year-after-the-launch-of-telaprevir-and-boceprevir-surveyed-physicians-expect-to-prescribe-triple-therapy-regimens-to-90-percent-of-their-hepatitis-c-virus-patients-2010-06-17?reflink=MW_news_stmp
June 17, 2010, 9:00 a.m. EDT
Twenty-Five Percent of Surveyed MCOs Expect to Add Both Telaprevir and Boceprevir to Their Formularies, According to a New Report from Decision Resources
WALTHAM, Mass., June 17, 2010 /PRNewswire via COMTEX/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, based on clinical profiles provided to them, surveyed clinicians estimate that one year after the launch of Vertex Pharmaceuticals/Johnson & Johnson/Mitsubishi Tanabe Pharma's telaprevir and Merck's boceprevir, at least 90 percent of hepatitis C virus (HCV) patients will be treated with triple therapy regimens.
The new Physician & Payer Forum report entitled Hepatitis C: Reimbursement and Uptake of Novel Antivirals Among Payers and Prescribers finds that surveyed physicians expect to treat 71 percent of treatment-naive and 78 percent of nonresponder patients with telaprevir/peg-IFN/ribavirin and 19 percent of treatment-naive and nonresponders with boceprevir/peg-IFN/ribavirin. Similar to clinicians, managed care organizations' (MCO) pharmacy directors are open to reimbursing telaprevir and boceprevir. However, surveyed pharmacy directors do not indicate a clear preference for either one of these protease inhibitors.
"Only 10 percent of the pharmacy directors we surveyed do not expect to add telaprevir or boceprevir to their drug formularies," said Decision Resources Analyst Alexandra Makarova, M.D. Ph.D. "The remaining surveyed pharmacy directors are split regarding the choice of the protease inhibitor for addition to their formularies. Twenty-five percent expect to add both telaprevir and boceprevir, while 15 percent will add only telaprevir and 5 percent will add only boceprevir. Forty percent of pharmacy directors will make their choice based on the relative cost of each agent."
The report also finds that almost half of surveyed clinicians indicate that they will use Roche's Pegasys and Merck's PegIntron interchangeably in combination with an HCV-specific antiviral agent even if this agent was evaluated in clinical trials involving only one of these peg-IFNs. However, one-third of doctors expect to combine a novel HCV-specific antiviral agent only with the peg-IFN that was used with the antiviral agent in clinical trials. These physicians indicate that they will likely use Pegasys in triple therapy regimens as the majority of HCV-specific antiviral agents are being evaluated with Pegasys rather than PegIntron.
Hepatitis C: Reimbursement and Uptake of Novel Antivirals Among Payers and Prescribers is based on a U.S. survey of 74 gastroenterologists, 26 hepatologists and 20 MCO pharmacy directors. Their responses were compared to assess similarities and differences of opinion regarding clinical, economic and scientific factors.
About Decision Resources
Decision Resources (www.decisionresources.com ) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com .
All company, brand, or product names contained in this document may be trademarks or
registered trademarks of their respective holders.
http://www.marketwatch.com/story/one-year-after-the-launch-of-telaprevir-and-boceprevir-surveyed-physicians-expect-to-prescribe-triple-therapy-regimens-to-90-percent-of-their-hepatitis-c-virus-patients-2010-06-17?reflink=MW_news_stmp
June 16, 2010
Congress to Hold Hepatitis Hearing this Thursday
Action Alert
(posted June 16, 2010)
Hepatitis C Advocates UNITED! Action Alert
Congress to Hold Hepatitis Hearing this Thursday
Urge Your Representative to Lead the Fight Against the “Secret Epidemic”
Background
On Thursday, June 17, the House Committee on Oversight and Government Reform will hold a hearing entitled “Viral Hepatitis: The Secret Epidemic.” This hearing, under the leadership of Chairman Edolphus Towns, will examine issues surrounding the prevention, detection, management and control of viral hepatitis.
This hearing provides an excellent opportunity to educate Members of Congress about the hepatitis B and C epidemics and the recommendations made earlier this year on how the federal government must improve its response in the Institute of Medicine (IOM) report, Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. The hearing also follows a major World Hepatitis Day rally at the U.S. Capitol nearly a month ago. There is growing momentum to demand that Congress fully fund hepatitis programs and take leadership on an issue that impacts millions of Americans.
Please take a few minutes to urge your House Representative to learn about the issues raised in this hearing and to fight for more viral hepatitis leadership!
Action
It is urgent that your calls be made immediately. Please call your Representative’s Washington, DC office. Ask to speak to the staff person who handles health issues. You can call your Representative at 202.225.3121. You will get the Capitol switchboard. Ask to be connected to your Representative’s office. If you don’t know who your Representative is, you can go online to http://www.house.gov/ to determine your Member of Congress. Whether you speak to this person directly or leave a message, tell them:
“My name is ___________ and I am a constituent of Representative ___________. I am calling to let you know about an important hearing this week on Thursday, June 17 at 10:00 AM held by the House Committee on Oversight and Government Reform entitled “Viral Hepatitis: The Secret Epidemic.” This hearing will focus on the federal government’s response to viral hepatitis; an epidemic that affects over 5 million Americans, most of whom do not know they are infected because they have no symptoms. Viral hepatitis such as hepatitis B and C are the leading causes of liver cancer and cause 15,000 premature deaths each year.
I urge Representative ___________ to support this hearing and to do everything he/she can to fight this silent epidemic, including fighting for increased funding for viral hepatitis programs at the Centers for Disease Control and Prevention, supporting in any way possible new health reform monies to hepatitis services and co-sponsoring the Viral Hepatitis and Liver Cancer Control and Prevention Act (H.R. 3974). This is important to me because _________________.”
It is especially important to encourage your Representative attend the hearing if he or she is on the House Committee on Oversight and Government Reform (see membership list below). Urge him/her to attend this important hearing to show leadership!
Committee Members:
Democrats:
Chairman Edolphus Towns (NY)
Paul Kanjorski (PA)
Carolyn Maloney (NY)
Elijah Cummings (MD)
Dennis Kucinich (OH)
John Tierney (MA)
William Lacy Clay (MO)
Diane Watson (CA)
Stephen Lynch (MA)
Jim Cooper (TN)
Gerald Connolly (VA)
Mike Quigley (IL)
Marcy Kaptur (OH)
Eleanor Holmes Norton (DC)
Patrick Kennedy (RI)
Danny Davis (IL)
Chris Van Hollen (MD)
Henry Cuellar (TX)
Paul Hodes (NH)
Christopher Murphy (CT)
Peter Welch (VT)
Bill Foster (IL)
Jackie Speier (CA)
Steve Driehaus (OH)
Judy Chu (CA)
Republicans:
Ranking Member Darrell Issa (CA)
Dan Burton (IN)
John Mica (FL)
John Duncan, Jr. (TN)
Michael Turner (OH)
Lynn Westmoreland (GA)
Patrick McHenry (NC)
Brian Bilbray (CA)
Jim Jordan (OH)
Jeff Flake (AZ)
Jeff Fortenberry (NE)
Jason Chaffetz (UT)
Aaron Schock (IL)
Blaine Luetkemeyer (MO)
Anh “Joseph” Cao (LA)
Hepatitis C Advocates UNITED! is a national, grassroots network of individuals and organizations fighting for increased funding for hepatitis programs and legislation to mount a comprehensive federal effort to fight the disease. We design grassroots strategies to educate our elected representatives about the need for adequate HCV funding and policies, including action alerts, sign-on letters legislative meetings, media activities, and other campaigns. We also share information and strategies on state-level issues and campaigns. Hepatitis C Advocates UNITED! was formed by the Hepatitis Appropriations Partnership (HAP) and the National Hepatitis C Advocacy Council (NHCAC), and the National Viral Hepatitis Roundtable (NVHR). To join the network, send an email to rclary@projectinform.org with “subscribe” in the subject field. Please include your name and city/state in the email.
Source
June 15, 2010
Hepatocellular Carcinoma—United States, 2001-2006
Vol. 303 No. 23, June 16, 2010
From the Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report
JAMA. 2010;303(23):2349-2350.
MMWR. 2010;59:517-520
1 figure, 2 tables omitted
Liver cancer, primarily hepatocellular carcinoma (HCC), is the third leading cause of death from cancer worldwide and the ninth leading cause of cancer deaths in the United States.1,2 Chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections account for an estimated 78% of global HCC cases.3 To determine trends in HCC incidence in the United States, CDC analyzed data for the period 2001-2006 (the most recent data available) from CDC's National Program of Cancer Registries (NPCR) and the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) surveillance system. This report summarizes the results of that analysis, which determined that the average annual incidence rate of HCC for 2001-2006 was 3.0 per 100,000 persons and increased significantly from 2.7 per 100,000 persons in 2001 to 3.2 in 2006, with an average annual percentage change in incidence rate (APC) of 3.5%. The largest increases in HCC incidence rates were among whites (APC = 3.8), blacks (APC = 4.8), and persons aged 50-59 years (APC = 9.1). Among states, HCC incidence rates varied widely, ranging from 1.4 per 100,000 in South Dakota to 5.5 in Hawaii. The results demonstrate a continuation of long-term increases in HCC incidence and persistent HCC racial/ethnic disparities. Development of viral hepatitis services, including screening with care referral for persons chronically infected with HBV or HCV, full implementation of vaccine-based strategies to eliminate hepatitis B, and improved public health surveillance are needed to help reverse the trend in HCC.
CDC examined all HCC cases diagnosed during 2001-2006 and reported to NPCR or SEER from 45 cancer registries (covering 90.4% of the U.S. population) that met the criteria for data quality and completeness.* Only microscopically confirmed HCC cases (coded to the liver ICD-O-3 site code C22.0 with ICD-O-3 histology codes 8170-8175) were included. Incidence rates per 100,000 persons were age adjusted to the 2000 U.S. standard population. APCs were calculated using least squares regression. Statistical significance was determined at p<0.05. Data were analyzed by state, sex, race, ethnicity, and age group. Persons categorized as either non-Hispanic or Hispanic might be of any race.
During 2001-2006, a total of 48,596 HCC cases were reported, with an average annual incidence rate of 3.0 per 100,000 persons. Overall, the HCC rate increased from 2.7 per 100,000 persons in 2001 to 3.2 in 2006, with an APC of 3.5%. The median age for diagnosis of HCC was 64 years overall, 62 years for males, and 69 years for females. The highest incidence rate was among persons aged 70-79 years (13.7), followed by persons aged 80 years (10.0), 60-69 years (9.6), 50-59 years (6.8), and 40-49 years (2.1).
The incidence rate for males (5.0 per 100,000 persons) was approximately three times higher than the rate for females (1.3). The HCC rate for males increased from 4.5 in 2001 to 5.4 in 2006, and the rate for females increased from 1.2 to 1.4. During 2001-2006, the APC for males (3.6%) was significantly higher than the APC for females (2.3%).
The HCC incidence rate was highest among Asians/Pacific Islanders (7.8 per 100,000 persons), followed by blacks (4.2), American Indians/Alaska Natives (3.2), and whites (2.6). The incidence rate for Hispanics (5.7 per 100,000 persons) was higher than the rate for non-Hispanics (2.8). From 2001 to 2006, the largest significant increases in HCC incidence rates were among whites (APC = 3.8), blacks (APC = 4.8), and persons aged 50-59 years (9.1). The HCC incidence rate did not increase among Asians/Pacific Islanders.
Among states, HCC incidence rates ranged from 1.4 per 100,000 persons in South Dakota to 5.5 in Hawaii. Eleven states had significant increases in incidence rates, with the highest APCs reported for Oklahoma (11.7), Iowa (9.0), and Georgia (7.4).
Reported by:
S O’Connor, MD, JW Ward, MD, Div of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; M Watson, MPH, B Momin, MPH, LC Richardson, MD, Div of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC.
CDC Editorial Note:
This report provides the most recent population-based estimates of HCC incidence rates and trends in the United States and the first state-specific HCC trends. The findings indicate continued increases in HCC incidence, consistent with earlier reports using different methodology.2,4 However, requiring microscopic confirmation of HCC likely produced more conservative incidence rate estimates than analyses of NPCR/SEER data published previously.2,4
Chronic HBV and HCV infections that persist for decades are major risk factors for HCC. Both infections cause chronic inflammation that can progress to fibrosis, cirrhosis, and eventually malignancy.3 HBV infection also can be directly oncogenic.3 In addition, alcohol consumption, steatohepatitis, and type II diabetes have been linked to HCC2; these risk factors for HCC amplify the effects of viral hepatitis but also might cause HCC in the absence of viral hepatitis.2
The age and race profile of persons with HCC reflects the demographic characteristics of persons with chronic viral hepatitis. During 2001-2006, HCC incidence was highest among Asians/Pacific Islanders, Hispanics (compared with non-Hispanics), blacks, persons aged 50 years, and males. The largest increases occurred among whites, blacks, persons aged 50-59 years, and males. Rates were highest among persons born during 1946-1964 (who are now aged 46-64 years), particularly black males.3,4 In the absence of testing and care, the risk for HCC is expected to increase with aging of the cohort of persons with HCV infection.5
Asians/Pacific Islanders, black adult males, and persons living in the United States who were born in regions where HBV is endemic (e.g., Asia and sub-Saharan Africa) have high rates of both HBV infection and HCC.2,5-8 As shown in this analysis, the rate of HCC did not increase among Asians/Pacific Islanders during 2001-2006. Some reasons for this might be early implementation of hepatitis B vaccination programs, changes in immigration patterns, and the impact of hepatitis B therapy on disease progression.3,4
The findings in this report are subject to at least three limitations. First, misclassification of race and ethnicity in the registries and multiracial status of patients might underestimate HCC rates in certain populations. Second, although some states collect information on specific Asian subgroups, these data are not available at the national level; published reports from selected geographic areas suggest that certain ethnic Asian/Pacific Islander subgroups have greater risk for HCC than other Asian/Pacific Islander subgroups.3 Finally, cancer registries do not routinely collect information on etiologic factors for HCC, including chronic viral hepatitis.
Most cases of HCC are preventable. Prevention of HBV and HCV transmission and progression of chronic viral disease leads to declines in HCC incidence.9 However, new HBV and HCV infections continue to occur.6,7 Populations at greatest risk for new infection include children born to HBV-infected mothers and adults with sexual and drug use risk behaviors. Of the estimated 3.8-5.3 million persons living with chronic viral hepatitis in the United States, most are unaware of their infection.5 Early identification of viral hepatitis with referral to prevention and care services can decrease transmission to others. Treatment of viral hepatitis is cost-effective, and medical management can decrease morbidity.10
In a recent report on prevention of hepatitis and liver cancer, the Institute of Medicine (IOM) called for a national comprehensive approach comprised of interventions to prevent HBV and HCV transmission and interventions to reduce the morbidity associated with chronic HBV and HCV infections.5 IOM recommends improved viral hepatitis surveillance, community education to address health disparities, support for vaccine-based strategies to eliminate HBV transmission, and development of prevention and health services that target key populations (i.e., drug users, foreign-born persons, and persons infected with human immunodeficiency virus), including screening for HBV and HCV infections linked to appropriate medical management.
What is already known on this topic?
Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in the United States and worldwide; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) accounts for an estimated 78% of global HCC cases.
What is added by this report?
During 2001-2006, HCC incidence rates increased in the United States, particularly among whites, blacks, and persons aged 50-59 years.
What are the implications for public health practice?
Development of viral hepatitis services, including screening with care referral for persons chronically infected with HBV or HCV, full implementation of vaccine-based strategies to eliminate hepatitis B, and improved public health surveillance are needed to help reverse the trend in HCC.
REFERENCES
10 Available.
* Detailed descriptions of the methods used by NCPR and SEER, including data collection and analysis, criteria for data inclusion, and determination of statistical significance are available at http://www.cdc.gov/cancer/npcr and http://seer.cancer.gov/ .
International Classification of Diseases for Oncology, 3rd ed.
http://jama.ama-assn.org/cgi/content/full/303/23/2349
From the Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report
JAMA. 2010;303(23):2349-2350.
MMWR. 2010;59:517-520
1 figure, 2 tables omitted
Liver cancer, primarily hepatocellular carcinoma (HCC), is the third leading cause of death from cancer worldwide and the ninth leading cause of cancer deaths in the United States.1,2 Chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections account for an estimated 78% of global HCC cases.3 To determine trends in HCC incidence in the United States, CDC analyzed data for the period 2001-2006 (the most recent data available) from CDC's National Program of Cancer Registries (NPCR) and the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) surveillance system. This report summarizes the results of that analysis, which determined that the average annual incidence rate of HCC for 2001-2006 was 3.0 per 100,000 persons and increased significantly from 2.7 per 100,000 persons in 2001 to 3.2 in 2006, with an average annual percentage change in incidence rate (APC) of 3.5%. The largest increases in HCC incidence rates were among whites (APC = 3.8), blacks (APC = 4.8), and persons aged 50-59 years (APC = 9.1). Among states, HCC incidence rates varied widely, ranging from 1.4 per 100,000 in South Dakota to 5.5 in Hawaii. The results demonstrate a continuation of long-term increases in HCC incidence and persistent HCC racial/ethnic disparities. Development of viral hepatitis services, including screening with care referral for persons chronically infected with HBV or HCV, full implementation of vaccine-based strategies to eliminate hepatitis B, and improved public health surveillance are needed to help reverse the trend in HCC.
CDC examined all HCC cases diagnosed during 2001-2006 and reported to NPCR or SEER from 45 cancer registries (covering 90.4% of the U.S. population) that met the criteria for data quality and completeness.* Only microscopically confirmed HCC cases (coded to the liver ICD-O-3 site code C22.0 with ICD-O-3 histology codes 8170-8175) were included. Incidence rates per 100,000 persons were age adjusted to the 2000 U.S. standard population. APCs were calculated using least squares regression. Statistical significance was determined at p<0.05. Data were analyzed by state, sex, race, ethnicity, and age group. Persons categorized as either non-Hispanic or Hispanic might be of any race.
During 2001-2006, a total of 48,596 HCC cases were reported, with an average annual incidence rate of 3.0 per 100,000 persons. Overall, the HCC rate increased from 2.7 per 100,000 persons in 2001 to 3.2 in 2006, with an APC of 3.5%. The median age for diagnosis of HCC was 64 years overall, 62 years for males, and 69 years for females. The highest incidence rate was among persons aged 70-79 years (13.7), followed by persons aged 80 years (10.0), 60-69 years (9.6), 50-59 years (6.8), and 40-49 years (2.1).
The incidence rate for males (5.0 per 100,000 persons) was approximately three times higher than the rate for females (1.3). The HCC rate for males increased from 4.5 in 2001 to 5.4 in 2006, and the rate for females increased from 1.2 to 1.4. During 2001-2006, the APC for males (3.6%) was significantly higher than the APC for females (2.3%).
The HCC incidence rate was highest among Asians/Pacific Islanders (7.8 per 100,000 persons), followed by blacks (4.2), American Indians/Alaska Natives (3.2), and whites (2.6). The incidence rate for Hispanics (5.7 per 100,000 persons) was higher than the rate for non-Hispanics (2.8). From 2001 to 2006, the largest significant increases in HCC incidence rates were among whites (APC = 3.8), blacks (APC = 4.8), and persons aged 50-59 years (9.1). The HCC incidence rate did not increase among Asians/Pacific Islanders.
Among states, HCC incidence rates ranged from 1.4 per 100,000 persons in South Dakota to 5.5 in Hawaii. Eleven states had significant increases in incidence rates, with the highest APCs reported for Oklahoma (11.7), Iowa (9.0), and Georgia (7.4).
Reported by:
S O’Connor, MD, JW Ward, MD, Div of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; M Watson, MPH, B Momin, MPH, LC Richardson, MD, Div of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC.
CDC Editorial Note:
This report provides the most recent population-based estimates of HCC incidence rates and trends in the United States and the first state-specific HCC trends. The findings indicate continued increases in HCC incidence, consistent with earlier reports using different methodology.2,4 However, requiring microscopic confirmation of HCC likely produced more conservative incidence rate estimates than analyses of NPCR/SEER data published previously.2,4
Chronic HBV and HCV infections that persist for decades are major risk factors for HCC. Both infections cause chronic inflammation that can progress to fibrosis, cirrhosis, and eventually malignancy.3 HBV infection also can be directly oncogenic.3 In addition, alcohol consumption, steatohepatitis, and type II diabetes have been linked to HCC2; these risk factors for HCC amplify the effects of viral hepatitis but also might cause HCC in the absence of viral hepatitis.2
The age and race profile of persons with HCC reflects the demographic characteristics of persons with chronic viral hepatitis. During 2001-2006, HCC incidence was highest among Asians/Pacific Islanders, Hispanics (compared with non-Hispanics), blacks, persons aged 50 years, and males. The largest increases occurred among whites, blacks, persons aged 50-59 years, and males. Rates were highest among persons born during 1946-1964 (who are now aged 46-64 years), particularly black males.3,4 In the absence of testing and care, the risk for HCC is expected to increase with aging of the cohort of persons with HCV infection.5
Asians/Pacific Islanders, black adult males, and persons living in the United States who were born in regions where HBV is endemic (e.g., Asia and sub-Saharan Africa) have high rates of both HBV infection and HCC.2,5-8 As shown in this analysis, the rate of HCC did not increase among Asians/Pacific Islanders during 2001-2006. Some reasons for this might be early implementation of hepatitis B vaccination programs, changes in immigration patterns, and the impact of hepatitis B therapy on disease progression.3,4
The findings in this report are subject to at least three limitations. First, misclassification of race and ethnicity in the registries and multiracial status of patients might underestimate HCC rates in certain populations. Second, although some states collect information on specific Asian subgroups, these data are not available at the national level; published reports from selected geographic areas suggest that certain ethnic Asian/Pacific Islander subgroups have greater risk for HCC than other Asian/Pacific Islander subgroups.3 Finally, cancer registries do not routinely collect information on etiologic factors for HCC, including chronic viral hepatitis.
Most cases of HCC are preventable. Prevention of HBV and HCV transmission and progression of chronic viral disease leads to declines in HCC incidence.9 However, new HBV and HCV infections continue to occur.6,7 Populations at greatest risk for new infection include children born to HBV-infected mothers and adults with sexual and drug use risk behaviors. Of the estimated 3.8-5.3 million persons living with chronic viral hepatitis in the United States, most are unaware of their infection.5 Early identification of viral hepatitis with referral to prevention and care services can decrease transmission to others. Treatment of viral hepatitis is cost-effective, and medical management can decrease morbidity.10
In a recent report on prevention of hepatitis and liver cancer, the Institute of Medicine (IOM) called for a national comprehensive approach comprised of interventions to prevent HBV and HCV transmission and interventions to reduce the morbidity associated with chronic HBV and HCV infections.5 IOM recommends improved viral hepatitis surveillance, community education to address health disparities, support for vaccine-based strategies to eliminate HBV transmission, and development of prevention and health services that target key populations (i.e., drug users, foreign-born persons, and persons infected with human immunodeficiency virus), including screening for HBV and HCV infections linked to appropriate medical management.
What is already known on this topic?
Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in the United States and worldwide; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) accounts for an estimated 78% of global HCC cases.
What is added by this report?
During 2001-2006, HCC incidence rates increased in the United States, particularly among whites, blacks, and persons aged 50-59 years.
What are the implications for public health practice?
Development of viral hepatitis services, including screening with care referral for persons chronically infected with HBV or HCV, full implementation of vaccine-based strategies to eliminate hepatitis B, and improved public health surveillance are needed to help reverse the trend in HCC.
REFERENCES
10 Available.
* Detailed descriptions of the methods used by NCPR and SEER, including data collection and analysis, criteria for data inclusion, and determination of statistical significance are available at http://www.cdc.gov/cancer/npcr and http://seer.cancer.gov/ .
International Classification of Diseases for Oncology, 3rd ed.
http://jama.ama-assn.org/cgi/content/full/303/23/2349
ESHG: SNP Linked to Outcomes in Hepatitis C Infection
Finding in IL28B locus associated with progression to chronic hepatitis infection, therapy failure
Jun 14, 2010
MONDAY, June 14 (HealthDay News) -- A single nucleotide polymorphism (SNP) in the gene encoding for interferon lambda is associated with progression to chronic hepatitis C infection and treatment failure, according to research presented at the annual conference of the European Society of Human Genetics, held from June 12 to 15 in Gothenburg, Sweden.
Zoltan Kutalik, Ph.D., of the University of Lausanne in Switzerland, and colleagues analyzed data from 1,362 patients with hepatitis C infection; 1,015 had chronic hepatitis C and 347 spontaneously cleared the virus. In 465 of the chronic patients, responses to pegylated interferon-alpha and ribavirin were assessed.
The researchers found that chronic hepatitis C was associated with SNPs in the IL28B locus, which encodes interferon-lambda-3, an antiviral cytokine. The minor allele of the SNP that was the top hit was linked to progression to chronic infection (odds ratio, 2.31). This association was seen in subjects with and without HIV co-infection. This SNP was also linked to failure to respond to therapy (odds ratio, 5.19).
"This disease affects up to 300 million people worldwide. It is insidious, and often individuals are not aware that they are infected until serious liver damage has taken place. Finding better treatments is vital. As well as sparing those who would not react well to current treatment from side effects, we hope that our work may provide pointers to the development of effective therapies for the future," Kutalik said in a statement.
Abstract No. C03.6
More Information
http://www.modernmedicine.com/modernmedicine/Modern+Medicine+Now/ESHG-SNP-Linked-to-Outcomes-in-Hepatitis-C-Infecti/ArticleNewsFeed/Article/detail/674310?contextCategoryId=40137
Jun 14, 2010
MONDAY, June 14 (HealthDay News) -- A single nucleotide polymorphism (SNP) in the gene encoding for interferon lambda is associated with progression to chronic hepatitis C infection and treatment failure, according to research presented at the annual conference of the European Society of Human Genetics, held from June 12 to 15 in Gothenburg, Sweden.
Zoltan Kutalik, Ph.D., of the University of Lausanne in Switzerland, and colleagues analyzed data from 1,362 patients with hepatitis C infection; 1,015 had chronic hepatitis C and 347 spontaneously cleared the virus. In 465 of the chronic patients, responses to pegylated interferon-alpha and ribavirin were assessed.
The researchers found that chronic hepatitis C was associated with SNPs in the IL28B locus, which encodes interferon-lambda-3, an antiviral cytokine. The minor allele of the SNP that was the top hit was linked to progression to chronic infection (odds ratio, 2.31). This association was seen in subjects with and without HIV co-infection. This SNP was also linked to failure to respond to therapy (odds ratio, 5.19).
"This disease affects up to 300 million people worldwide. It is insidious, and often individuals are not aware that they are infected until serious liver damage has taken place. Finding better treatments is vital. As well as sparing those who would not react well to current treatment from side effects, we hope that our work may provide pointers to the development of effective therapies for the future," Kutalik said in a statement.
Abstract No. C03.6
More Information
http://www.modernmedicine.com/modernmedicine/Modern+Medicine+Now/ESHG-SNP-Linked-to-Outcomes-in-Hepatitis-C-Infecti/ArticleNewsFeed/Article/detail/674310?contextCategoryId=40137
Better Clarity on Diagnosis Facilitates the Introduction of Novel Treatments in the Hepatitis C Therapeutics Market in Australia, Finds Frost & Sulliv
SINGAPORE, June 15 /PRNewswire/ -- Physicians expect the rate of diagnosis to continue rising in Australia due to heightening of awareness among general practitioners regarding screening and treatment for Hepatitis C. Screening of Hepatitis C patients in Australia, especially among illicit drug users, has resulted in a spike in the number of diagnosed cases of Hepatitis C virus (HCV). In 2009, an estimated 77 percent of patients-at-risk with Hepatitis C were diagnosed, and this figure is expected to reach up to 87 percent by 2016.
(Logo: http://photos.prnewswire.com/prnh/20081117/FSLOGO)
Higher efficacy and safety are the most preferred drug attributes. Physicians expect new oral anti-virals (boceprevir and telaprivir) and interferon with improved safety (albuferon) to be launched by 2013 in Australia. According to physicians, prevalence had increased rapidly during the early 2000s. However, the rate had declined over the years, and the pace is likely to slacken in the future owing to a major disruption to the supply of heroin in Australia in 2001.
New analysis from Frost & Sullivan (http://www.pharma.frost.com), Multi Client Study: Opportunities Assessment for the Hepatitis C Therapeutics Market in Australia, finds that the market earned revenues of $2.3 billion in 2007 and this is expected to increase to approximately $4.5 billion by 2017 due to new drug launches occurring after 2010.
"The Australian Government has unleashed Initiatives to address the Hepatitis C virus in the country, allocating $14.3 million (Australian dollar 17 million) for Hepatitis C education and prevention over the 2007-2011 period," says Frost & Sullivan Program Manager Carole Gaffud. "State and territory governments also have substantial budgets for Hepatitis C prevention and education."
The priority action areas identified as part of the National Hepatitis C Strategy are prevention, education, diagnosis, treatment, surveillance, and research. The Government is avidly addressing healthcare workforce development as well as issues surrounding discrimination and stigma.
Although there is a high diagnosis rate in Australia, only a paltry 3 percent of diagnosed patients pursue treatment owing to a lack of understanding about treatment options. According to physicians, one of the main reasons for such a large proportion of diagnosed patients left untreated is that they are predominantly from disadvantaged groups such as illicit drug users, aboriginal people, those serving prison sentences, and some migrant groups, which do not have access to conventional healthcare. Often the reason is real or perceived stigma and discrimination.
Aside from this, there is a great deal of angst about debilitating side effects, frequent dosing, and lackluster efficacy of the existing HCV treatments, especially for those afflicted with genotype 1. Moreover, there is a belief that a liver biopsy is required to receive treatment, which deters patients from undergoing treatment.
To circumvent the challenges clouding the market landscape, companies must offer treatment options that expedite efficiency, have fewer side effects, and are cost efficient. Patients should be made aware of their disease status and encouraged to remain compliant.
"As more improvements are required to educate at risk patients, public and private organizations including pharmaceutical companies must up the ante to spread awareness," says Gaffud. "Greater information outreach will help patients obtain the right mode of treatment and ultimately stem the onslaught of the Hepatitis C virus in Australia.
If you are interested in more information on this study, please send an e-mail to Nicklaus Au, Corporate Communications, at nicklaus.au@frost.com, with your full name, company name, title, telephone number, company e-mail address, company website, city, state and country.
Multi Client Study: Opportunities Assessment for the Hepatitis C Therapeutics Market in Australia is part of the Pharmaceutical & Biotechnology Growth Partnership Services program, which also includes research in the following markets: Opportunities Assessment of Hepatitis C Market in Taiwan, Opportunities Assessment of Hepatitis C in Philippines, Opportunities Assessment of Hepatitis C in Indonesia, Opportunities Assessment of Hepatitis C in Singapore, Opportunities Assessment of Hepatitis C in China, Opportunities Assessment of Hepatitis C in Thailand, Opportunities Assessment of Hepatitis C in Hong Kong, Opportunities Assessment of Hepatitis C in India, Opportunities Assessment of Hepatitis C in Korea, and Opportunities Assessment of Hepatitis C in Malaysia. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.
About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 40 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com.
http://www.prnewswire.com/news-releases/better-clarity-on-diagnosis-facilitates-the-introduction-of-novel-treatments-in-the-hepatitis-c-therapeutics-market-in-australia-finds-frost--sullivan-96353094.html
(Logo: http://photos.prnewswire.com/prnh/20081117/FSLOGO)
Higher efficacy and safety are the most preferred drug attributes. Physicians expect new oral anti-virals (boceprevir and telaprivir) and interferon with improved safety (albuferon) to be launched by 2013 in Australia. According to physicians, prevalence had increased rapidly during the early 2000s. However, the rate had declined over the years, and the pace is likely to slacken in the future owing to a major disruption to the supply of heroin in Australia in 2001.
New analysis from Frost & Sullivan (http://www.pharma.frost.com), Multi Client Study: Opportunities Assessment for the Hepatitis C Therapeutics Market in Australia, finds that the market earned revenues of $2.3 billion in 2007 and this is expected to increase to approximately $4.5 billion by 2017 due to new drug launches occurring after 2010.
"The Australian Government has unleashed Initiatives to address the Hepatitis C virus in the country, allocating $14.3 million (Australian dollar 17 million) for Hepatitis C education and prevention over the 2007-2011 period," says Frost & Sullivan Program Manager Carole Gaffud. "State and territory governments also have substantial budgets for Hepatitis C prevention and education."
The priority action areas identified as part of the National Hepatitis C Strategy are prevention, education, diagnosis, treatment, surveillance, and research. The Government is avidly addressing healthcare workforce development as well as issues surrounding discrimination and stigma.
Although there is a high diagnosis rate in Australia, only a paltry 3 percent of diagnosed patients pursue treatment owing to a lack of understanding about treatment options. According to physicians, one of the main reasons for such a large proportion of diagnosed patients left untreated is that they are predominantly from disadvantaged groups such as illicit drug users, aboriginal people, those serving prison sentences, and some migrant groups, which do not have access to conventional healthcare. Often the reason is real or perceived stigma and discrimination.
Aside from this, there is a great deal of angst about debilitating side effects, frequent dosing, and lackluster efficacy of the existing HCV treatments, especially for those afflicted with genotype 1. Moreover, there is a belief that a liver biopsy is required to receive treatment, which deters patients from undergoing treatment.
To circumvent the challenges clouding the market landscape, companies must offer treatment options that expedite efficiency, have fewer side effects, and are cost efficient. Patients should be made aware of their disease status and encouraged to remain compliant.
"As more improvements are required to educate at risk patients, public and private organizations including pharmaceutical companies must up the ante to spread awareness," says Gaffud. "Greater information outreach will help patients obtain the right mode of treatment and ultimately stem the onslaught of the Hepatitis C virus in Australia.
If you are interested in more information on this study, please send an e-mail to Nicklaus Au, Corporate Communications, at nicklaus.au@frost.com, with your full name, company name, title, telephone number, company e-mail address, company website, city, state and country.
Multi Client Study: Opportunities Assessment for the Hepatitis C Therapeutics Market in Australia is part of the Pharmaceutical & Biotechnology Growth Partnership Services program, which also includes research in the following markets: Opportunities Assessment of Hepatitis C Market in Taiwan, Opportunities Assessment of Hepatitis C in Philippines, Opportunities Assessment of Hepatitis C in Indonesia, Opportunities Assessment of Hepatitis C in Singapore, Opportunities Assessment of Hepatitis C in China, Opportunities Assessment of Hepatitis C in Thailand, Opportunities Assessment of Hepatitis C in Hong Kong, Opportunities Assessment of Hepatitis C in India, Opportunities Assessment of Hepatitis C in Korea, and Opportunities Assessment of Hepatitis C in Malaysia. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.
About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 40 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com.
http://www.prnewswire.com/news-releases/better-clarity-on-diagnosis-facilitates-the-introduction-of-novel-treatments-in-the-hepatitis-c-therapeutics-market-in-australia-finds-frost--sullivan-96353094.html
Indian Oncologists have performed Treatment of Primary Liver Cancer in India at an Incredible Success Rate
2010-06-15 12:23:10 - primary liver cancer treatment India, primary liver cancer treatment, primary liver cancer cure, oncologists India, cancer treatment India, cancer treatment hospitals India, cancer hospitals, oncologists India, liver treatment India, medical tourism India, low cost liver cancer treatment India, cost treatment India
Indian oncologists providing treatment of Primary liver cancer in India has been a pioneer in this field. Indian hospitals are equipped to handle all phases of myeloma problems from the elementary to the latest clinical procedures. The commitment of its surgeons to the prevention and treatment of myeloma has led to the achievement of better outcomes and improved quality of life for thousands of patients. Indian hospitals providing treatment of Primary liver cancer in India ensure that patient’s experience is safe and comfortable, with the highest standards of both medical and non-medical services.
What is Primary Liver Cancer?
Primary liver cancer is one of the less common cancers in Victoria with about 260 people diagnosed each year. It is more common in men and people aged over 65 years. Most primary liver cancers start in liver cells (hepatocellular carcinoma); others start in a bile duct (cholangiocarcinoma). In the Western world, most people who develop Primary liver cancer also have cirrhosis of the liver. This is scarring of the liver due to causes including heavy alcohol drinking over a long period of time. However, only a small number of people who have cirrhosis of the liver develop primary liver cancer. Infection with hepatitis B, C or D can also increase the risk of cirrhosis and, later, Primary liver cancer.
Benefits vs. RisksBenefits:
• Chemoembolization can stop liver tumors from growing or cause them to shrink in 2/3 of cases treated. This benefit, on average, lasts 10-14 months.• Chemoembolization can be used in conjunction with other cancer treatments including tumor ablation, radiation and chemotherapy.
• Most patients don't die from the spread of cancer if it is confined to the liver, but rather from liver failure caused by the tumors growth. Chemoembolization can help prevent the growth of a tumor, preserving liver function and a relatively normal quality of life.
• Two randomized controlled trials published in 2002 showed improved survival in patients with hepatoma (primary liver cancer) after chemoembolization compared to supportive care alone.
Risks:
• Embolus (tiny particles) can lodge in the wrong place and deprive normal tissue of its blood supply.
• Even if antibiotics are given, there is always a risk of infection after embolization.
• There is a risk of an allergic reaction to the dye used in the angiography x-ray.
• There is a risk of kidney damage in patients with diabetes or other pre-existing kidney disease due to the angiography.
• Nausea, hair loss, decreases in white blood cells and platelets, and anemia may occur due to the chemotherapy drug.
• After 1 in 20 procedures, serious complications occur and typically include liver infection or damage to the liver. Liver failure is usually the cause of the 1 in 100 deaths related to this procedure.
Causes and Risk factors for Primary Liver Cancer
The exact cause of primary liver cancer is still unknown. There are a number of factors, however, that increase your risk of developing it.
These include: -
• Liver cirrhosis: In the Western world, most people who develop hepatoma usually also have a condition called cirrhosis of the liver. This is a fine scarring throughout the liver which is due to a variety of causes including infection and heavy alcohol drinking over a long period of time. However, only a small proportion of people who have cirrhosis of the liver develop Primary liver cancer.
• Infection: Infection with either the hepatitis B or hepatitis C virus can lead to liver cancer. This can also be the cause of cirrhosis, which in turn increases the risk of developing hepatoma. The risk is greater in those that also smoke.
• Inherited conditions: People who have a condition called haemochromatosis, which causes excess deposits of iron in the body, or the condition alpha 1 antitrypsin deficiency, have a higher chance of developing hepatoma.
• Aflatoxin: In Africa and Asia a poison called aflatoxin, found in mouldy peanuts and grain, is a major cause of hepatoma.
Diagnosis
Liver cancer is usually diagnosed with a number of different tests, which may include: -
• Blood tests - to check your general health and to check for a chemical usually found in increased levels in people with primary liver cancer.
• Ultrasound - a picture of the liver is taken using sound waves.
• CT scan - a specialised x-ray taken from many different angles to build a three-dimensional (3-D) picture of the body.
• Magnetic resonance imaging (MRI) - similar to a CT scan, but uses magnetism instead of x-rays to build a picture of the body.
• Liver biopsy - a small piece of liver tissue is removed with a needle and examined for cancer cells.
• Laparoscopy - a small cut in the lower abdomen allows a thin mini-telescope (laparoscope) to be inserted to look at the liver and take a sample of the liver tissue.
What are the treatment options for Liver Cancer?
The treatment options for Primary liver cancers are dictated by the stage of liver cancer and the overall condition of the patient. The only proven cure for liver cancer is liver transplantation for a solitary, small (<3cm) tumor. Now, many physicians may dispute this statement. They may argue that a small tumor can be surgically removed (partial hepatic resection) without the need for a liver transplantation. Moreover, they may claim that the one and three year survival rates for resection are perhaps comparable to those for liver transplantation. Why India? Treatment of Primary liver cancer in India is done under best medical supervision. The reason India is a favorable destination is because of its infrastructure and technology which is in par with developed countries. India has some of the best hospitals and treatment centers in the world with the best facilities. India has state of the art Hospitals and the best qualified doctors. With the best infrastructure, the best possible Medical facilities, accompanied with the most competitive prices, you can get the treatment done in India at the lowest charges. For further details on the treatment of Primary liver cancer in India, visit us at : http://www.forerunnershealthcare.com/ . Call us at: +91-9371136499, +91- 9860755000 (International) / + 1-415-599-2537 (USA) / +44-20-8133-2571 (UK)
Please Send Queries On: www.forerunnershealthcare.com/enquiry_form.php
Watch International Patient Videos: www.forerunnershealthcare.com/International-patient-videos.html
http://www.pr-inside.com/indian-oncologists-have-performed-treatment-r1949445.htm
Indian oncologists providing treatment of Primary liver cancer in India has been a pioneer in this field. Indian hospitals are equipped to handle all phases of myeloma problems from the elementary to the latest clinical procedures. The commitment of its surgeons to the prevention and treatment of myeloma has led to the achievement of better outcomes and improved quality of life for thousands of patients. Indian hospitals providing treatment of Primary liver cancer in India ensure that patient’s experience is safe and comfortable, with the highest standards of both medical and non-medical services.
What is Primary Liver Cancer?
Primary liver cancer is one of the less common cancers in Victoria with about 260 people diagnosed each year. It is more common in men and people aged over 65 years. Most primary liver cancers start in liver cells (hepatocellular carcinoma); others start in a bile duct (cholangiocarcinoma). In the Western world, most people who develop Primary liver cancer also have cirrhosis of the liver. This is scarring of the liver due to causes including heavy alcohol drinking over a long period of time. However, only a small number of people who have cirrhosis of the liver develop primary liver cancer. Infection with hepatitis B, C or D can also increase the risk of cirrhosis and, later, Primary liver cancer.
Benefits vs. RisksBenefits:
• Chemoembolization can stop liver tumors from growing or cause them to shrink in 2/3 of cases treated. This benefit, on average, lasts 10-14 months.• Chemoembolization can be used in conjunction with other cancer treatments including tumor ablation, radiation and chemotherapy.
• Most patients don't die from the spread of cancer if it is confined to the liver, but rather from liver failure caused by the tumors growth. Chemoembolization can help prevent the growth of a tumor, preserving liver function and a relatively normal quality of life.
• Two randomized controlled trials published in 2002 showed improved survival in patients with hepatoma (primary liver cancer) after chemoembolization compared to supportive care alone.
Risks:
• Embolus (tiny particles) can lodge in the wrong place and deprive normal tissue of its blood supply.
• Even if antibiotics are given, there is always a risk of infection after embolization.
• There is a risk of an allergic reaction to the dye used in the angiography x-ray.
• There is a risk of kidney damage in patients with diabetes or other pre-existing kidney disease due to the angiography.
• Nausea, hair loss, decreases in white blood cells and platelets, and anemia may occur due to the chemotherapy drug.
• After 1 in 20 procedures, serious complications occur and typically include liver infection or damage to the liver. Liver failure is usually the cause of the 1 in 100 deaths related to this procedure.
Causes and Risk factors for Primary Liver Cancer
The exact cause of primary liver cancer is still unknown. There are a number of factors, however, that increase your risk of developing it.
These include: -
• Liver cirrhosis: In the Western world, most people who develop hepatoma usually also have a condition called cirrhosis of the liver. This is a fine scarring throughout the liver which is due to a variety of causes including infection and heavy alcohol drinking over a long period of time. However, only a small proportion of people who have cirrhosis of the liver develop Primary liver cancer.
• Infection: Infection with either the hepatitis B or hepatitis C virus can lead to liver cancer. This can also be the cause of cirrhosis, which in turn increases the risk of developing hepatoma. The risk is greater in those that also smoke.
• Inherited conditions: People who have a condition called haemochromatosis, which causes excess deposits of iron in the body, or the condition alpha 1 antitrypsin deficiency, have a higher chance of developing hepatoma.
• Aflatoxin: In Africa and Asia a poison called aflatoxin, found in mouldy peanuts and grain, is a major cause of hepatoma.
Diagnosis
Liver cancer is usually diagnosed with a number of different tests, which may include: -
• Blood tests - to check your general health and to check for a chemical usually found in increased levels in people with primary liver cancer.
• Ultrasound - a picture of the liver is taken using sound waves.
• CT scan - a specialised x-ray taken from many different angles to build a three-dimensional (3-D) picture of the body.
• Magnetic resonance imaging (MRI) - similar to a CT scan, but uses magnetism instead of x-rays to build a picture of the body.
• Liver biopsy - a small piece of liver tissue is removed with a needle and examined for cancer cells.
• Laparoscopy - a small cut in the lower abdomen allows a thin mini-telescope (laparoscope) to be inserted to look at the liver and take a sample of the liver tissue.
What are the treatment options for Liver Cancer?
The treatment options for Primary liver cancers are dictated by the stage of liver cancer and the overall condition of the patient. The only proven cure for liver cancer is liver transplantation for a solitary, small (<3cm) tumor. Now, many physicians may dispute this statement. They may argue that a small tumor can be surgically removed (partial hepatic resection) without the need for a liver transplantation. Moreover, they may claim that the one and three year survival rates for resection are perhaps comparable to those for liver transplantation. Why India? Treatment of Primary liver cancer in India is done under best medical supervision. The reason India is a favorable destination is because of its infrastructure and technology which is in par with developed countries. India has some of the best hospitals and treatment centers in the world with the best facilities. India has state of the art Hospitals and the best qualified doctors. With the best infrastructure, the best possible Medical facilities, accompanied with the most competitive prices, you can get the treatment done in India at the lowest charges. For further details on the treatment of Primary liver cancer in India, visit us at : http://www.forerunnershealthcare.com/ . Call us at: +91-9371136499, +91- 9860755000 (International) / + 1-415-599-2537 (USA) / +44-20-8133-2571 (UK)
Please Send Queries On: www.forerunnershealthcare.com/enquiry_form.php
Watch International Patient Videos: www.forerunnershealthcare.com/International-patient-videos.html
http://www.pr-inside.com/indian-oncologists-have-performed-treatment-r1949445.htm
Prediction of prognostic biomarkers for Interferon-based therapy to Hepatitis C Virus patients : a metaanalysis of the NS5A protein in subtypes 1a, 1b
Hepatitis C virus (HCV) is a worldwide health problem with no vaccine and the only approved therapy is Interferon-based plus Ribavarin. Response prediction to treatment has health and economic impacts, and is a multi-factorial problem including both host and viral factors (e.g: age, sex, ethnicity, pre-treatment viral load, and dynamics of the HCV non-structural protein NS5A quasispecies).
We implement a novel approach for extracting features including informative markers from mutations in the non-structural 5A protein (NS5A), specifically its ISDR and V3 regions, and use a novel bioinformatics approach for pattern recognition on the NS5A protein and its motifs to find biomarkers for response prediction using class association rules (CARs) and comparing the predictability of the different features.
Results: A total of 58 sequences from sustained responders and 94 from non-responders were downloaded from the HCV LANL database. Site-specific signatures for response prediction from the NS5A protein were extracted from the alignments.
CARs were generated (e.g.: sustained response is associated with position A2368T in subtype 1a (support 100% and confidence 52.19%); in subtype 1b, response is associated with E2356G/D/K (support 76.3% and confidence 67.3%).
Conclusion: The V3 region was a more accurate biomarker than the ISDR region. Subtype-specific CARs gave better support and confidence than hidden Markov models HMMs scores, genetic distances (GDs) or number of variable sites (NVS), and would thus aid in the prediction of prognostic biomarkers and improve the accuracy of prognosis.
Sites-specific CARs in the V3 region of the NS5A protein have given the best support and confidence.
Author: Mahmoud ElHefnawiSuher ZadaIman El-AzabCredits/Source: Virology Journal 2010, 7:130
Published on: 2010-06-15
http://7thspace.com/headlines/347795/
prediction_of_prognostic_biomarkers_for_interferon_based_therapy_to_hepatitis_c_virus
_patients___a_metaanalysis_of_the_ns5a_protein_in_subtypes_1a_1b_and_3a.html
We implement a novel approach for extracting features including informative markers from mutations in the non-structural 5A protein (NS5A), specifically its ISDR and V3 regions, and use a novel bioinformatics approach for pattern recognition on the NS5A protein and its motifs to find biomarkers for response prediction using class association rules (CARs) and comparing the predictability of the different features.
Results: A total of 58 sequences from sustained responders and 94 from non-responders were downloaded from the HCV LANL database. Site-specific signatures for response prediction from the NS5A protein were extracted from the alignments.
CARs were generated (e.g.: sustained response is associated with position A2368T in subtype 1a (support 100% and confidence 52.19%); in subtype 1b, response is associated with E2356G/D/K (support 76.3% and confidence 67.3%).
Conclusion: The V3 region was a more accurate biomarker than the ISDR region. Subtype-specific CARs gave better support and confidence than hidden Markov models HMMs scores, genetic distances (GDs) or number of variable sites (NVS), and would thus aid in the prediction of prognostic biomarkers and improve the accuracy of prognosis.
Sites-specific CARs in the V3 region of the NS5A protein have given the best support and confidence.
Author: Mahmoud ElHefnawiSuher ZadaIman El-AzabCredits/Source: Virology Journal 2010, 7:130
Published on: 2010-06-15
http://7thspace.com/headlines/347795/
prediction_of_prognostic_biomarkers_for_interferon_based_therapy_to_hepatitis_c_virus
_patients___a_metaanalysis_of_the_ns5a_protein_in_subtypes_1a_1b_and_3a.html
NVHR Launches Targeted Print Advertising Campaign Urging Swift Congressional Action on Secret Epidemic of Chronic Viral Hepatitis
WASHINGTON, June 15 /PRNewswire-USNewswire/ -- As Congress prepares to shine a spotlight this week on chronic viral hepatitis, the National Viral Hepatitis Roundtable (NVHR) today launched a new targeted print advertising campaign to urge swift action on bipartisan legislation providing federal funding for state-based screening and early intervention programs. NVHR's new advertising initiative comes in advance of a hearing Thursday, June 17, before the full House Oversight & Government Reform Committee, chaired by Chairman Ed Towns (D-NY) and Ranking Member Darrell Issa (R-Calif.). The Committee has invited testimony from a diverse panel of witnesses who will offer strategies for implementing expert recommendations made earlier this year by the Institute of Medicine (IOM).
NVHR is a coalition of more than 175 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. www.nvhr.org
"NVHR's new advertising initiative is a timely reminder to Congress, the Administration, and all stakeholders that federal action is desperately needed this year to help combat this insidious disease that affects over 5 million Americans and their loved ones," said Ms. Lorren Sandt, Chair of the National Viral Hepatitis Roundtable (NVHR) and Executive Director of Caring Ambassadors Program, based in Portland, OR. "Six months ago, the Institute of Medicine issued nearly two-dozen expert recommendations for improving the federal government's response to the viral hepatitis epidemic. The pressing challenge now before Congress and the Administration is to provide federal funding to translate the IOM report into swift and decisive action."
Under the banner of "Mission: Possible," NVHR's new advertisement highlights the IOM report and urges action on HR 3974. The advertisement also features the tagline "If Congress gets on the case now, the leading cause of liver cancer won't stand a chance."
Thursday's hearing before the House Oversight & Government Reform Committee is an important step forward in this fight. An estimated 5.3 million Americans have been infected with chronic viral hepatitis B or C – and with most unaware of their infection, millions are at risk of developing life-threatening complications, especially African Americans and Asian Americans. Without detection and treatment, chronic viral hepatitis leads to liver cancer, cirrhosis, or liver failure. In the absence of federal leadership, the research firm Milliman estimates that public and private payers' cost of treating chronic viral hepatitis C alone will more than triple by 2024 to $85 billion annually. Medicare and Medicaid would absorb a disproportionate share of these added costs.
HR 3974, "The Viral Hepatitis and Liver Cancer Control and Prevention Act," is sponsored by Representatives Mike Honda (D-Calif.), Charles Dent (R-Pa.) and 49 other House Members and would help turn the tide. The Honda-Dent legislation would increase the ability of the CDC to support state health departments in their prevention, immunization and surveillance, and referral to care efforts. Much of the Honda-Dent legislation tracks with the IOM's recommendations.
SOURCE National Viral Hepatitis Roundtable
RELATED LINKS
http://www.nvhr.org/
http://www.prnewswire.com/news-releases/nvhr-launches-targeted-print-advertising-campaign-urging-swift-congressional-action-on-secret-epidemic-of-chronic-viral-hepatitis-96379309.html
NVHR is a coalition of more than 175 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. www.nvhr.org
"NVHR's new advertising initiative is a timely reminder to Congress, the Administration, and all stakeholders that federal action is desperately needed this year to help combat this insidious disease that affects over 5 million Americans and their loved ones," said Ms. Lorren Sandt, Chair of the National Viral Hepatitis Roundtable (NVHR) and Executive Director of Caring Ambassadors Program, based in Portland, OR. "Six months ago, the Institute of Medicine issued nearly two-dozen expert recommendations for improving the federal government's response to the viral hepatitis epidemic. The pressing challenge now before Congress and the Administration is to provide federal funding to translate the IOM report into swift and decisive action."
Under the banner of "Mission: Possible," NVHR's new advertisement highlights the IOM report and urges action on HR 3974. The advertisement also features the tagline "If Congress gets on the case now, the leading cause of liver cancer won't stand a chance."
Thursday's hearing before the House Oversight & Government Reform Committee is an important step forward in this fight. An estimated 5.3 million Americans have been infected with chronic viral hepatitis B or C – and with most unaware of their infection, millions are at risk of developing life-threatening complications, especially African Americans and Asian Americans. Without detection and treatment, chronic viral hepatitis leads to liver cancer, cirrhosis, or liver failure. In the absence of federal leadership, the research firm Milliman estimates that public and private payers' cost of treating chronic viral hepatitis C alone will more than triple by 2024 to $85 billion annually. Medicare and Medicaid would absorb a disproportionate share of these added costs.
HR 3974, "The Viral Hepatitis and Liver Cancer Control and Prevention Act," is sponsored by Representatives Mike Honda (D-Calif.), Charles Dent (R-Pa.) and 49 other House Members and would help turn the tide. The Honda-Dent legislation would increase the ability of the CDC to support state health departments in their prevention, immunization and surveillance, and referral to care efforts. Much of the Honda-Dent legislation tracks with the IOM's recommendations.
SOURCE National Viral Hepatitis Roundtable
RELATED LINKS
http://www.nvhr.org/
http://www.prnewswire.com/news-releases/nvhr-launches-targeted-print-advertising-campaign-urging-swift-congressional-action-on-secret-epidemic-of-chronic-viral-hepatitis-96379309.html
FDA Warning: Natural Products Supplier Makes False Claims for HIV and Hepatitis
http://www.fda.gov/
-FDA posted the linked warning letter regarding unjustified HIV and hepatitis claims by a natural products supplier-
Healthy World Distributing
5/11/10
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Seattle DistrictPacific Region22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996
May 11, 2010
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-22
Dr. Leonard G. Horowitz
Healthy World Distributing, LLC
206 North 4th Avenue, Suite #147
Sandpoint, Idaho 83864
Jacqueline G. LindenBach
Mary Johnson
Healing Celebrations, LLC
217 Cedar Street, #326
Sandpoint, Idaho 83864
WARNING LETTER
Dear Dr. Horowitz, Ms. LindenBach and Ms. Johnson:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your integrated system of promotional websites and labeling for your "Oxysilver," "PrimoLife," "ZeoLife," "Green Harvest," "ElectrOEnyzmes," "OxySilver Immune Support Hydrosol Concentrate," "GI Flora Pro," "OxyAdvantage," and "Love Minerals" products. We have reviewed the internet addresses where these products are sold, www.oxysilver.com, www.healthyworldambassadors.com and www.healthyworldstore.com. and have determined that they are promoted for conditions that cause them to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].
The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease, and/or in the case of your products marketed for topical use, because they are intended to affect the structure or function of the human body. The marketing of your products with these claims violates section 505(a) of the Act [21 U.S.C. § 355(a)]. In addition, your products Oxysilver, Green Harvest, ElectrOEnzymes, and OxySilver Immune Support Hydrosol Concentrate fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
In addition, your websites listed below automatically redirect to http://www.oxysilver.com/ :
http://www.aquasilver.net/,
http://www.aquasilver.us/,
http://www.aguasilver.org/,
http://www.hydrosil.info/,
http://www.hydrosilver.net/,
http://www.hydrosilver.us/,
http://www.hydrosol.org/,
http://www.hydrosolcures.com/,
http://www.hydrosolcures.info/,
http://www.hydrosolcures.net/,
http://www.hydrosolcures.org/,
http://www.hydrosolcures.us/,
http://www.hydroxysol.com/,
http://www.hydroxysol.net/,
http://www.oxysilver.info/,
http://www.oxysilver.net/,
http://www.oxysilverclub.net/,
http://www.oxysilvercure.com/,
http://www.oxysilvercure.info/,
http://www.oxysilvercure.net/,
http://www.oxysilvercure.org/,
http://www.oxysilverhydrosolution.com/,
http://www.oxysilverhydrosolution.info/ ,
http://www.oxysilverhydrosolution.net/,
http://www.oxysilverhydrosolution.org/ ,
http://www.oxysilverimmunization.com/,
http://www.oxysilverimmunization.info/ ,
http://www.oxysilverimmunization.net/,
http://www.oxysilverimmunization.org/,
http://www.oxysolution.com/,
http://www.silveroxygenhydrosol.com/,
http://www.silveroxygenhydrosol.info/,
http://www.silveroxygenhydrosol.net/,
http://www.silveroxygenhydrosol.org/ ,
-FDA posted the linked warning letter regarding unjustified HIV and hepatitis claims by a natural products supplier-
Healthy World Distributing
5/11/10
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Seattle DistrictPacific Region22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996
May 11, 2010
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-22
Dr. Leonard G. Horowitz
Healthy World Distributing, LLC
206 North 4th Avenue, Suite #147
Sandpoint, Idaho 83864
Jacqueline G. LindenBach
Mary Johnson
Healing Celebrations, LLC
217 Cedar Street, #326
Sandpoint, Idaho 83864
WARNING LETTER
Dear Dr. Horowitz, Ms. LindenBach and Ms. Johnson:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your integrated system of promotional websites and labeling for your "Oxysilver," "PrimoLife," "ZeoLife," "Green Harvest," "ElectrOEnyzmes," "OxySilver Immune Support Hydrosol Concentrate," "GI Flora Pro," "OxyAdvantage," and "Love Minerals" products. We have reviewed the internet addresses where these products are sold, www.oxysilver.com, www.healthyworldambassadors.com and www.healthyworldstore.com. and have determined that they are promoted for conditions that cause them to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].
The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease, and/or in the case of your products marketed for topical use, because they are intended to affect the structure or function of the human body. The marketing of your products with these claims violates section 505(a) of the Act [21 U.S.C. § 355(a)]. In addition, your products Oxysilver, Green Harvest, ElectrOEnzymes, and OxySilver Immune Support Hydrosol Concentrate fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
In addition, your websites listed below automatically redirect to http://www.oxysilver.com/ :
http://www.aquasilver.net/,
http://www.aquasilver.us/,
http://www.aguasilver.org/,
http://www.hydrosil.info/,
http://www.hydrosilver.net/,
http://www.hydrosilver.us/,
http://www.hydrosol.org/,
http://www.hydrosolcures.com/,
http://www.hydrosolcures.info/,
http://www.hydrosolcures.net/,
http://www.hydrosolcures.org/,
http://www.hydrosolcures.us/,
http://www.hydroxysol.com/,
http://www.hydroxysol.net/,
http://www.oxysilver.info/,
http://www.oxysilver.net/,
http://www.oxysilverclub.net/,
http://www.oxysilvercure.com/,
http://www.oxysilvercure.info/,
http://www.oxysilvercure.net/,
http://www.oxysilvercure.org/,
http://www.oxysilverhydrosolution.com/,
http://www.oxysilverhydrosolution.info/ ,
http://www.oxysilverhydrosolution.net/,
http://www.oxysilverhydrosolution.org/ ,
http://www.oxysilverimmunization.com/,
http://www.oxysilverimmunization.info/ ,
http://www.oxysilverimmunization.net/,
http://www.oxysilverimmunization.org/,
http://www.oxysolution.com/,
http://www.silveroxygenhydrosol.com/,
http://www.silveroxygenhydrosol.info/,
http://www.silveroxygenhydrosol.net/,
http://www.silveroxygenhydrosol.org/ ,
http://www.silveroxygenhydrosolution.com/,
http://www.silveroxyhydrosol.com/,
http://www.silveroxyhydrosol.info/,
http://www.silveroxyhydrosol.org/,
http://www.silveroxysolution.com/,
http://www.silveroxysolution.net/,
http://www.theoxysilverclub.com/,
http://www.theoxysilverclub.info/,
http://www.theoxysilverclub.net/,
http://www.theoxysilverclub.org/,
http://www.theoxysilvercure.com/,
http://www.theoxysilvercure.info/,
http://www.theoxysilvercure.net/,
http://www.theoxysilvercure.org/, and
http://www.theoxysilvercure.us/.
Also, your websites listed below promote Oxysilver with "buy" links or a graphic representation of Oxysilver that links directly to http://www.oxysilver.com/:
http://www.fluscam.com/,
http://www.fluscam.tv/,
http://www.swinefluscam.info/,
http://www.love528tv.com/,
http://www.healthyworldshop.com/,
http://www.love528.net/,
http://www.healthyworldsolutions.com/,
http://www.alternativehealthcarenow.org/,
http://www.alternativehealthcarenow.com/,
http://www.drleonardhorowitz.com/,
http://www.drhorowitz.info/,
http://www.lenin528.com/,
http://www.natureslovingessence.com/,
http://www.natureslovingessence.info/, and
http://www.natureslovingessence.net/.
In addition, your websites listed below automatically redirect to the opening page of http://www.healthyworldstore.com/:
http://www.hydrosonicevolution.info/,
http://www.hydrosonicevolution.net/,
http://www.hydrosonicevolution.com/,
http://www.hydrosonicevolution.org/,
http://www.selfcaremall.com/,
http://www.selfcarestore.net/,
http://www.selfhealthdepot.com/,
http://www.vibrate528.org/,
http://www.vibrationalhealing.name/,
http://www.vibrationalmedicine.name/, and
http://www.vibrationalmedicineonline.com/ .
1. Claims on www.oxysilver.com
The website address http://www.oxysilver.com/ appears on your Oxysilver product label.
Examples of some of the claims observed on your http://www.oxysilver.com/ website include:
Oxysilver
The following are claims that stream at the top of your www.oxysilver.com home page:
• "Destroy Viruses, Bacteria, and Fungi"
• "Eliminate the need for harmful vaccines and anti-biotics[sic]"
Additional claims found on your www.oxysilver.com home page include:
• "Silver hydrosols, in general, are superior powerful broad spectrum anti-microbials."
• "[Silver hydrosols are] alternatives to ...poisonous antibiotics, and risky vaccinations."
• "Can you Imagine a world free of infectious diseases, viral cancers, and AIDS? Some people can't imagine this, including the major corporations producing risky expensive antibiotics and intoxicating vaccines (i.e., Oxysilver's competition)."
The following claims are found on the page that opens from the "Technology" tab on the http://www.oxysilver.com/ home page:
• . "[S]ilver hydrosols, in general destroy pathogens safer and better than anything. They pioneered silver hydrosols effective against disease forming bacteria; viruses, and fungi."
• "OXYSILVERTM serves as the world's first nutraceutical alternative to risky vaccinationsand immunizations... "
• "[T]hese solutions are safe and effective adjuncts and alternatives to risky antibiotics and chemotherapeutics. This breakthrough evolutionizes disease prevention, germ elimination... "
• "Substantial scientific research proves silver hydrosols destroy pathogens-disease forming bacteria, viruses, and fungi-in your body... "
• "Take the burden off your immune system with OXYSILVERTM...developed to strengthen natural immunity against infectious diseases and common chronic ailments largely attributable to weakened immune systems."
Your http://www.oxysilver.com/ website also contains disease claims in the form of personal testimonials. These testimonials are examples of those found on the page that opens from the "Validation" tab on your home page:
• "I wanted to let you know how well the OxySilver has worked for me. I have had trouble with recurring bladder and kidney infections and interstitial cystitis. My pains hurt so bad that it was hard to sit down at times. Within two days of taking OxySilver at the recommended dosage as per the bottle, I was able to go to the bathroom without burning anymore. This is much better than other treatments which did nothing for me."
• "DIABETES SYMPTOMS RELIEVED 'I have been a diabetic for most of my life. As I have gotten older I have gradually been taking more and more insulin. After just one week on OxySilver for the first time I can remember I am actually taking less insulin. I have also noticed that my blood sugar levels have stabilized considerably. I would highly recommend the use of OxySilver to anyone suffering from any level of diabetes. '"
• "RELIEF FROM SINUS HEADACHES 'I have suffered from chronic sinus headaches for most of my adult life; I'm 50 years old now. Miraculously since I've begun taking OXYSLIVER [sic], I've had many days and nights now of no pain at all. I can honestly tell you, nothing I have ever done has had nearly the positive effect on my Sinus condition and I seem to be continuously improving.'"
• "BRONCHITIS SYMPTOMS GONE 'I had the fortunate experience of a personal visit of a member of your executive staff to my home. After much convincing by him, I agreed to try some Oxysilver as a potential remedy for my chronic bronchitis. I'm very pleased to report that not only is my bronchitis completely gone, but I am feeling better than I can ever recall feeling after 20 years of continuous bronchitis.'"
• "RELIEF FROM KNEE PAIN DUE TO HEPATITIS VACCINATIONS 'As a result of several hepatitis vaccinations I ... started experiencing joint pains especially in my left knee. The pain became so severe I couldn't walk a quarter of a mile on level ground. After taking OXYSLIVER [sic] for approximately one month, my knee pain has almost completely disappeared.'''
• "GULF WAR SYNDROME SYMPTOMS GONE 'In late 1999, I was in and out of the VA Hospital suffering from Gulf War Syndrome. I had aches and pains and zero energy. I was introduced to Oxysilver by some close friends. After taking the mineral solution for several months, I now have no symptoms and I'm as healthy as ever."
• "HIGH FEVERS IN TODDLERS RELIEVED 'I had to take my 18 month & 28 month old daughters to the emergency Medi-Center one Sunday morning last winter with 103 degree temperatures. I avoid taking them because my husband and I want to minimize the number of drugs our children receive. My husband came home from church with Oxysilver for the girls. I hadn't filled the prescriptions yet - I wanted to believe in this new mineral solution so decided to give it (the mineral solution) 24 hrs. Before filling the prescriptions, I gave the girls 1 oz. three times during that afternoon and evening. The next morning their fevers had broken - and within 2-3 days they were fine.'
• "RELIEF FROM LUPUS SYMPTOMS OF PAIN AND FATIGUE 'In fall 1998, I went to the doctor with symptoms such as joint pains and chronic fatigue. They performed a blood test and the results came back positive with Lupus. ... A friend asked me to try Oxysilver and see if it would help relieve the symptoms. I started drinking a quart a day for two weeks, and I started to feel better. I could finally sleep throughout the night, and my mornings were much easier now that I was able to get out of bed. After eight months of using Oxysilver, I went back to the doctor for a blood test, and this time there was no sign of Lupus in the blood work. The doctor states that it is in remission, Oxysilver did what no prescribed medication or diet could accomplish, and that was relieve my pain and fatigue."
• "HEPATITIS C SYMPTOMS RELIEVED 'Thanks again for the opportunity to try Oxysilver. Hepatitis C had my life in such a state of affairs. '" My liver enzymes were at their worst and my viral load was dangerously high. Now my liver is normal and the viral load is coming down.'"
The claims quoted above are supplemented by the metatags used to bring consumers to your http://www.oxysilver.com/ website through Internet searches. The metatags include:
• "hep b, hep c, hepatitis b, hepatitis c, rnrsa, fibromyalgia, Cancers, HIV, AIDS ... virus, viruses, germs, bacteria ... Vaccine ... antibiotics ... flu ... infectious .. : high fevers, lupus, typhus infection ... fungus, fungi ... pathogens, disease forming bacteria ... anaerobic germs, germicides ...."
In addition, the following claims in the form of personal testimonials marketing the OxySilver™ product for topical uses were found on the page that opens from the "Validation" tab on your http://www.oxysilver.com/ website:
• "I developed an infection in my right eye. ... I got an eye dropper that I had in my kitchen and filled it with OXYSILVER and dropped two drops in my eye. When I woke up the next morning and looked at my eye. The puss and redness and swelling were gone and I was amazed!"
• "QUICK RELIEF FROM TYPHUS INFECTION AND PAIN IN LEG ... 'I was suffering from typhus in my left leg. I wrapped gauze around my leg and poured Oxysilver onto the wrapping. Within 2 to 3 hours, the pain was gone, and that same day the infection was also gone.'"
When intended for topical use, Oxysilver is not a dietary supplement because the Act defines the term "dietary supplement" in 201(ff)(2)(A)(i) of the Food Drug and Cosmetic Act (21 U.S.C. § 321(ff)(2)(A)(i)), as a product that is "intended for ingestion." Topical products and products intended to enter the body directly through the skin or mucosal tissues are not dietary supplements. The above testimonials suggesting that consumers use Oxysilver topically subject the product to regulation as a drug. Thus, Oxysilver is a drug under 201(g)(1)(B)/(C) of the Act (21 U.S.C. §321(g)(1)(B)/(C)), because it is intended to affect the structure or function of the human body and/or to prevent, treat or cure disease conditions.
2. Claims on www.healthyworldambassadors.com
Examples of some of the claims observed on your www.healthyworldambassadors.com website include:
Oxysilver:
• "This mineral water electrocutes germs safely and powerfully!"
• "It promotes vaccine-free natural nutritional immunity against infectious diseases without immunization toxicity."
• "OXYSILVERTM is ... developed to strengthen natural immunity against infectious diseases and common chronic ailments largely attributable to weakened immune systems.
3. Claims on www.healthyworldstore.com
Examples of some of the claims observed on your website http://www.healthyworldstore.com/ include the following:
PrimoLife
• "PrimoLife... possesses the secrets of living disease-free ... enhance your immune system's ability to identify and destroy germs and diseased cells."
2009 Flu Package Special (includes PrimoLife, Oxysilver, Zeolife, GI Flora Pro, OxyAdvantage, and Love Minerals)
• The hyperlink "Don't be fooled by the H1N1 Swine Flu Scam. The Vaccine is Deadly. Get this kit and Save" links to a webpage titled "2009 Flu Package Special," which states, "This package contains assorted immunity boosters and health enhancers that, when you are using responsibly, guarantee you will stay healthy, no matter who or what kind of animal around you gets sick."
Green Harvest
• "Green Harvest contains ingredients helping people beat cancer. .. "
ElectrOEnzymes
• "[ElectrOEnzymes is] also for those who have used antibiotics that have killed natural gut flora."
• "Here is what ElectrOEnyzmes can do for you: Gastrointestinal repair ... Reduces allergies ... Reduces build-up of arterial plaque"
Oxysilver Immune Support Hydrosol Concentrate
• "Oxysilver is an effective alternative to risky vaccinations and deadly antibiotics. It promotes vaccine-free natural nutritional immunity against infectious diseases without immunization toxicity."
• "OXYSILVER is ... developed to strengthen natural immunity against infectious diseases and common chronic ailments largely attributable to weakened immune systems."
• "This product destroys pathogens-disease forming bacteria, viruses, and fungi .... "
• "What's entirely unique about this product [Oxysilver Immune Support Hydrosol Concentrate] is that theoretically it can prevent and cure any disease affected by oxygen, which is the vast majority of ailments from colds to cancers."
The claims quoted above are supplemented by the metatags used to bring consumers to your http://www.healthvworldstore.com/ website through Internet searches. The metatags include:
• "anti-microbiaL .. autism ... cancer. .. virus, viruses infection... antibiotics... flu, Cancer Cure... Flu Formula... H1N1, pandemic ... swine flu emerging viruses."
Your products OxySilver, PrimoLife, ZeoLife, Green Harvest, ElectrOEnzymes, OxySilver Immune Support Hydrosol Concentrate, GI Flora Pro, OxyAdvantage, and Love Minerals are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(P)]. Under section 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
Furthermore, because your Oxysilver, Green Harvest, ElectrOEnyzmes, and OxySilver Immune Support Hydrosol Concentrate, products are offered for conditions that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use the products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. Sections 302 and 304 of the Act authorize the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to: Lisa Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington, 98021-4421. If you have any questions regarding any issues in this letter, please contact Ms. Althar at (425) 483-4906.
Sincerely,
/s/
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Deborah Autor
Director
Office of Compliance
Center for Drug Evaluation and Research
Charles M. Breen C.
Director
Seattle District Office
http://www.hcvadvocate.org/news/False_claims.html
June 14, 2010
Breast Cancer Patients with HCV Can Be Treated with Cytotoxic Therapy
http://www.medwire-news.md
By Laura Dean
MedWire News: Patients with breast cancer and chronic hepatitis C virus (HCV) infection can be treated effectively with cytotoxic chemotherapy, US researchers have found.
“Although HCV is the most common blood-borne infection in the United States, little information exists about treatment of breast cancer in the setting of chronic HCV,” note Phuong Khanh Morrow and colleagues from the University of Texas MD Anderson Cancer Center in Houston.
To gain further insight, Morrow and colleagues retrospectively reviewed data for 45 patients (98% women) with invasive breast cancer and HCV who were treated at the MD. Anderson Cancer Center between 2000 and 2008.
In all, 36 (80%) patients received chemotherapy for their breast cancer. The remaining nine patients received either endocrine therapy alone (n=7), or no systemic therapy at all (n=2).
During chemotherapy, nine (25%) patients experienced elevations in aminotransferases and 16 (44%) patients required dose reductions, or had delays in chemotherapy.
“In almost all cases, dose reductions or delays were necessitated by complications of therapy, rather than due to elevations of transaminases,” say Morrow et al.
“However, it is possible that elevations in baseline transaminases could have contributed to the side effects observed, as liver function is a determinant of the metabolism of several of the chemotherapeutic agents utilized,” they add.
There was a high rate (63.9%) of complications that were grade 2 or greater, based on the National Cancer Institute Common Terminology Criteria for Adverse Events. The most common complications were neutropenic fever or infection, non-neutropenic infection, and neuropathy.
In spite of this, the vast majority (92%) of patients were able to complete the number of cycles specified in the initial chemotherapy plan.
“As the majority of these breast cancer patients completed the initial chemotherapy plan, this study indicates that breast cancer patients with HCV can be treated with cytotoxic therapy,” conclude Morrow and co-authors in the Annals of Oncology.
“Comparison with historical controls showed similar rates of hepatic toxicity in the presence (or absence) of HCV, indicating that incidence of transaminitis may not be significantly affected by HCV,” they add.
Ann Oncol 2010; 21: 1233–1236
http://www.hcvadvocate.org/news/newsRev/2010/NewsRev-365.html#_Breast_Cancer_Patients
By Laura Dean
MedWire News: Patients with breast cancer and chronic hepatitis C virus (HCV) infection can be treated effectively with cytotoxic chemotherapy, US researchers have found.
“Although HCV is the most common blood-borne infection in the United States, little information exists about treatment of breast cancer in the setting of chronic HCV,” note Phuong Khanh Morrow and colleagues from the University of Texas MD Anderson Cancer Center in Houston.
To gain further insight, Morrow and colleagues retrospectively reviewed data for 45 patients (98% women) with invasive breast cancer and HCV who were treated at the MD. Anderson Cancer Center between 2000 and 2008.
In all, 36 (80%) patients received chemotherapy for their breast cancer. The remaining nine patients received either endocrine therapy alone (n=7), or no systemic therapy at all (n=2).
During chemotherapy, nine (25%) patients experienced elevations in aminotransferases and 16 (44%) patients required dose reductions, or had delays in chemotherapy.
“In almost all cases, dose reductions or delays were necessitated by complications of therapy, rather than due to elevations of transaminases,” say Morrow et al.
“However, it is possible that elevations in baseline transaminases could have contributed to the side effects observed, as liver function is a determinant of the metabolism of several of the chemotherapeutic agents utilized,” they add.
There was a high rate (63.9%) of complications that were grade 2 or greater, based on the National Cancer Institute Common Terminology Criteria for Adverse Events. The most common complications were neutropenic fever or infection, non-neutropenic infection, and neuropathy.
In spite of this, the vast majority (92%) of patients were able to complete the number of cycles specified in the initial chemotherapy plan.
“As the majority of these breast cancer patients completed the initial chemotherapy plan, this study indicates that breast cancer patients with HCV can be treated with cytotoxic therapy,” conclude Morrow and co-authors in the Annals of Oncology.
“Comparison with historical controls showed similar rates of hepatic toxicity in the presence (or absence) of HCV, indicating that incidence of transaminitis may not be significantly affected by HCV,” they add.
Ann Oncol 2010; 21: 1233–1236
http://www.hcvadvocate.org/news/newsRev/2010/NewsRev-365.html#_Breast_Cancer_Patients
A New Target for Hepatitis C Virus
http://www.virology.ws
by Vincent Racaniello
When infection with hepatitis C virus goes from acute to chronic, severe liver disease may occur which requires organ transplantation. Nearly 200 million people are chronically infected with HCV, necessitating approaches to preventing and treating infections. No HCV vaccine is available, and current antiviral therapy consists of administration of interferon plus ribavirin, a combination that is effective about half the time and is associated with undesirable side effects. New antiviral compounds that target a viral protease and RNA polymerase are currently in clinical trials may eventually reach the market. But our experience with HIV-1 has shown that combinations of three drugs are the most effective for derailing the emergences of drug resistant viruses. The third target for HCV could be NS5A, a viral protein without a known function.
To identify new inhibitors of HCV, a chemical library of one million compounds was screened for the ability to inhibit viral replication in cell culture. The active compound were then subjected to a second screen to eliminate inhibitors of known viral enzymes: the viral protease, RNA polymerase, and helicase. One of the remaining inhibitors was further refined chemically until a very potent derivative was obtained. This molecule, called BMS-790052, has a 50% inhibitory concentration in the picomolar range, and inhibits all the viral genotypes tested. It is the most powerful inhibitor of HCV discovered.
The compound was tested for safety and bioavailability in various animal species. After oral administration, the compound was found in plasma and liver, despite a molecular mass of over 700 daltons. Six different levels of the compound were tested in HCV infected individuals. No adverse effects were reported, and the highest amount administered reduced viral levels in the blood 2,000 fold after one day. These results are promising, but larger trials will now be needed to further confirm the safety and efficacy of the drug.
What is the target of BMS-790052? Two lines of evidence suggest that the compound inhibits the viral protein NS5A. The drug appears to bind NS5A, and viruses resistant to the drug have amino acid changes in this protein. Although NS5A is known to be required for viral replication, its precise function is not known. Because NS5A does not have an easily assayable enzymatic function, it has not previously been a target of drug discovery. The identification of a compound that inhibits NS5A function is an important step forward in HCV drug development. The general approach used to discover BMS-790052 should be useful in identifying inhibitors of other viral proteins that do not have well defined and measurable activities.
I discussed this paper on Futures in Biotech episode #60. If you would like to listen only to the conversation about BMS-790052, download this mp3 file.
Gao M, Nettles RE, Belema M, Snyder LB, Nguyen VN, Fridell RA, Serrano-Wu MH, Langley DR, Sun JH, O’Boyle DR 2nd, Lemm JA, Wang C, Knipe JO, Chien C, Colonno RJ, Grasela DM, Meanwell NA, & Hamann LG (2010). Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature, 465 (7294), 96-100 PMID: 20410884
http://www.hcvadvocate.org/news/newsRev/2010/NewsRev-365.html#_A_New_Target
by Vincent Racaniello
When infection with hepatitis C virus goes from acute to chronic, severe liver disease may occur which requires organ transplantation. Nearly 200 million people are chronically infected with HCV, necessitating approaches to preventing and treating infections. No HCV vaccine is available, and current antiviral therapy consists of administration of interferon plus ribavirin, a combination that is effective about half the time and is associated with undesirable side effects. New antiviral compounds that target a viral protease and RNA polymerase are currently in clinical trials may eventually reach the market. But our experience with HIV-1 has shown that combinations of three drugs are the most effective for derailing the emergences of drug resistant viruses. The third target for HCV could be NS5A, a viral protein without a known function.
To identify new inhibitors of HCV, a chemical library of one million compounds was screened for the ability to inhibit viral replication in cell culture. The active compound were then subjected to a second screen to eliminate inhibitors of known viral enzymes: the viral protease, RNA polymerase, and helicase. One of the remaining inhibitors was further refined chemically until a very potent derivative was obtained. This molecule, called BMS-790052, has a 50% inhibitory concentration in the picomolar range, and inhibits all the viral genotypes tested. It is the most powerful inhibitor of HCV discovered.
The compound was tested for safety and bioavailability in various animal species. After oral administration, the compound was found in plasma and liver, despite a molecular mass of over 700 daltons. Six different levels of the compound were tested in HCV infected individuals. No adverse effects were reported, and the highest amount administered reduced viral levels in the blood 2,000 fold after one day. These results are promising, but larger trials will now be needed to further confirm the safety and efficacy of the drug.
What is the target of BMS-790052? Two lines of evidence suggest that the compound inhibits the viral protein NS5A. The drug appears to bind NS5A, and viruses resistant to the drug have amino acid changes in this protein. Although NS5A is known to be required for viral replication, its precise function is not known. Because NS5A does not have an easily assayable enzymatic function, it has not previously been a target of drug discovery. The identification of a compound that inhibits NS5A function is an important step forward in HCV drug development. The general approach used to discover BMS-790052 should be useful in identifying inhibitors of other viral proteins that do not have well defined and measurable activities.
I discussed this paper on Futures in Biotech episode #60. If you would like to listen only to the conversation about BMS-790052, download this mp3 file.
Gao M, Nettles RE, Belema M, Snyder LB, Nguyen VN, Fridell RA, Serrano-Wu MH, Langley DR, Sun JH, O’Boyle DR 2nd, Lemm JA, Wang C, Knipe JO, Chien C, Colonno RJ, Grasela DM, Meanwell NA, & Hamann LG (2010). Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature, 465 (7294), 96-100 PMID: 20410884
http://www.hcvadvocate.org/news/newsRev/2010/NewsRev-365.html#_A_New_Target
Sustained Virological Response at 12 Weeks Post-treatment May be as Good as 24 Weeks for Determining Interferon Cure
SUMMARY: People who continue to have undetectable hepatitis C virus (HCV) viral load 12 weeks after completing a course of therapy -- sometimes called SVR-12 -- are as likely to remain free of the virus over the long term as those tested 24 weeks post-treatment, according to a study published in the April 2010 issue of Hepatology. This suggests that clinical trial results 12 weeks after finishing treatment may be an accurate measure of sustained virological response.
By Liz Highleyman
Sustained virological response (SVR) to hepatitis C treatment is usually defined as continued undetectable HCV viral load 24 weeks after completion of therapy. Michelle Martinot-Peignoux and colleagues from France evaluated whether assessment of serum HCV RNA 12 weeks after the end of treatment was as relevant as 24 weeks for determining SVR.
The investigators analyzed sustained treatment outcomes among 573 chronic hepatitis C patients who received pegylated interferon (Pegasys or PegIntron) plus ribavirin and had an end-of-treatment virological response. Viral load was measured using a sensitive TMA assay with a lower limit of 5-10 IU/mL. Viral relapse was defined as reappearance of detectable HCV-RNA between the end of treatment and post-treatment week 24.
Results
"Institut National de la Santé et de la Recherche Médicale, Centre de Recherche Biomédicale Bichat-Beaujon CRB3, Université Paris VII, Paris, France; Service d'Hépatologie, Hopital Beaujon, Clichy, France.
6/11/10
Reference
M Martinot-Peignoux, C Stern, S Maylin, and others. Twelve weeks posttreatment follow-up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin. Hepatology 51(4):1122-1126 (Abstract). April 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0611_2010_a.html
By Liz Highleyman
Sustained virological response (SVR) to hepatitis C treatment is usually defined as continued undetectable HCV viral load 24 weeks after completion of therapy. Michelle Martinot-Peignoux and colleagues from France evaluated whether assessment of serum HCV RNA 12 weeks after the end of treatment was as relevant as 24 weeks for determining SVR.
The investigators analyzed sustained treatment outcomes among 573 chronic hepatitis C patients who received pegylated interferon (Pegasys or PegIntron) plus ribavirin and had an end-of-treatment virological response. Viral load was measured using a sensitive TMA assay with a lower limit of 5-10 IU/mL. Viral relapse was defined as reappearance of detectable HCV-RNA between the end of treatment and post-treatment week 24.
Results
- All 573 participants had undetectable HCV RNA at the end of treatment.
- At 12 weeks post-treatment, 409 participants still had undetectable viral load.
- At 24 weeks post-treatment, 408 participants (71%) achieved SVR.
- Looking back at week 12 results, all but 1 of the patients who were undetectable at week 12 remained so at week 24.
- Week 12 response had a positive predictive value of 99.7% for predicting Week 24 SVR.
"Institut National de la Santé et de la Recherche Médicale, Centre de Recherche Biomédicale Bichat-Beaujon CRB3, Université Paris VII, Paris, France; Service d'Hépatologie, Hopital Beaujon, Clichy, France.
6/11/10
Reference
M Martinot-Peignoux, C Stern, S Maylin, and others. Twelve weeks posttreatment follow-up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin. Hepatology 51(4):1122-1126 (Abstract). April 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0611_2010_a.html
Presidio Pharmaceuticals Selects PPI-1301 as Second Hepatitis C Virus NS5A Inhibitor for Development
SUMMARY: Presidio Pharmaceuticals announced late last month that it has selected a second hepatitis C virus (HCV) NS5A inhibitor -- designated PPI-1301 -- for further testing in clinical trials. The function of the NS, or non-structural, 5A sequence in the HCV genome is not fully understood, but it appears to play a role in viral replication. Combining NS5A inhibitors with HCV protease (NS3/4A) and polymerase (NS5B) inhibitors may increase antiviral potency and slow emergence of drug resistance.
Below is an excerpt from a recent Presidio press release describing the selection of PPI-1301.
Presidio Pharmaceuticals, Inc. Selects SecondClinical Candidate From Hepatitis C Virus NS5A Inhibitor Program
San Francisco, CA -- May 26, 2010 -- Presidio Pharmaceuticals, Inc. announced today that they have selected a second clinical candidate, PPI-1301, from their hepatitis C virus (HCV) NS5A program for advancement into clinical development. Presidio's first NS5A inhibitor, PPI-461, is currently undergoing evaluation in a Phase 1a clinical study.
Inhibitors of the HCV NS5A protein represent an exciting, highly potent class that is distinct from other classes of HCV antivirals that target the viral protease or replicase. With poor response and tolerance issues associated with the current standard of care treatment -- pegylated-IFN [interferon] and ribavirin -- there is clear need for more potent and better tolerated inhibitors that can be administered orally in future combination therapies.
PPI-1301 was derived from a chemical series that is distinct from PPI-461, but similar to PPI-461, exhibits potent and selective activity against all HCV genotypes in HCV replicon assays. PPI-1301 also shows good oral bioavailability and tolerance in animal studies, with elevated liver concentrations relative to serum levels, as well as the potential for once daily dosing in humans. IND-enabling studies for PPI-1301 are currently underway.
"The selection of PPI-1301 underscores Presidio's continued commitment to generating best-in class compounds for treating HCV," commented Richard Colonno, PhD, Chief Scientific Officer, who added, "The advancement of PPI-1301 further demonstrates the breadth and depth of our NS5A program pipeline."
About Presidio Presidio Pharmaceuticals, Inc. is a San Francisco-based specialty pharmaceutical company dedicated to the discovery and development of small-molecule antiviral therapeutics for novel and validated targets. For more information, please visit our website at: http://www.presidiopharma.com/.
6/15/10
SourcePresidio Pharmaceuticals. Presidio Pharmaceuticals, Inc. Selects Second Clinical Candidate From Hepatitis C Virus NS5A Inhibitor Program. Press release. May 26, 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0615_2010_a.html
Below is an excerpt from a recent Presidio press release describing the selection of PPI-1301.
Presidio Pharmaceuticals, Inc. Selects SecondClinical Candidate From Hepatitis C Virus NS5A Inhibitor Program
San Francisco, CA -- May 26, 2010 -- Presidio Pharmaceuticals, Inc. announced today that they have selected a second clinical candidate, PPI-1301, from their hepatitis C virus (HCV) NS5A program for advancement into clinical development. Presidio's first NS5A inhibitor, PPI-461, is currently undergoing evaluation in a Phase 1a clinical study.
Inhibitors of the HCV NS5A protein represent an exciting, highly potent class that is distinct from other classes of HCV antivirals that target the viral protease or replicase. With poor response and tolerance issues associated with the current standard of care treatment -- pegylated-IFN [interferon] and ribavirin -- there is clear need for more potent and better tolerated inhibitors that can be administered orally in future combination therapies.
PPI-1301 was derived from a chemical series that is distinct from PPI-461, but similar to PPI-461, exhibits potent and selective activity against all HCV genotypes in HCV replicon assays. PPI-1301 also shows good oral bioavailability and tolerance in animal studies, with elevated liver concentrations relative to serum levels, as well as the potential for once daily dosing in humans. IND-enabling studies for PPI-1301 are currently underway.
"The selection of PPI-1301 underscores Presidio's continued commitment to generating best-in class compounds for treating HCV," commented Richard Colonno, PhD, Chief Scientific Officer, who added, "The advancement of PPI-1301 further demonstrates the breadth and depth of our NS5A program pipeline."
About Presidio Presidio Pharmaceuticals, Inc. is a San Francisco-based specialty pharmaceutical company dedicated to the discovery and development of small-molecule antiviral therapeutics for novel and validated targets. For more information, please visit our website at: http://www.presidiopharma.com/.
6/15/10
SourcePresidio Pharmaceuticals. Presidio Pharmaceuticals, Inc. Selects Second Clinical Candidate From Hepatitis C Virus NS5A Inhibitor Program. Press release. May 26, 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0615_2010_a.html
Pharmasset Announces Submission of Abstracts to AASLD Liver Meeting Including an Interim Analysis of
Pharmasset, Inc. announced today that the interim results from the PROPEL study conducted by its partner Roche demonstrate that RG7128 triple combination therapy was safe and well tolerated. In that study, the safety profile of RG7128 (1000mg BID or 500mg BID), when administered for 8 or 12 weeks with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), the standard of care (SOC), was similar to the safety profile of SOC alone. An interim analysis of the study included all safety data from all 408 patients who had completed the first 12 weeks of the study. The most common adverse events were no different than those frequently noted with SOC alone. There were no findings related to rash, anemia, bone marrow suppression, or nephrotoxicity across any of the arms.
The PROPEL study is evaluating the dose and duration of treatment of RG7128 in combination with SOC in patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 4 who have not been treated previously. The interim analysis also included on-treatment efficacy data demonstrating that >80% of patients had undetectable HCV RNA in all cohorts receiving the 12-week triple regimen compared to <50% for the placebo/SOC cohort. The safety and efficacy results from the interim analysis of the PROPEL Phase 2b study of RG7128 have been submitted by Roche as an abstract to AASLD for the Annual Liver Meeting (October 29 to November 2, 2010).
The title of the abstract is:
"High rates of early viral response, promising safety profile and lack of resistance-related breakthrough in HCV GT 1/4 patients treated with RG7128 plus PegIFN alfa-2a (40KD)/RBV: Planned Week 12 interim analysis from the PROPEL study"
"We are encouraged by the reported efficacy, safety, and resistance data from this interim analysis of the PROPEL study," said M. Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We believe safety, absence of resistance, as well as antiviral potency will all be important considerations as HCV treatment incorporates direct acting antivirals in combination with interferon, and in potential interferon-free antiviral combination regimens."
No viral rebounds or resistance-related breakthroughs were noted during the first 8 or 12 weeks of triple combination therapy, consistent with the demonstrated high barrier to resistance in earlier RG7128 clinical studies. In clinical reports to date, the S282T mutation associated with RG7128 resistance in vitro has not been detected at baseline in HCV-infected patients enrolling in clinical trials. A separate abstract has been submitted by Roche including details of the resistance analyses that have been conducted during this study, including sequencing of the HCV RNA from all patients at baseline. The abstract is entitled:
"No evidence of drug resistance or baseline S282T resistance mutation among GT1 and GT4 HCV infected patients on nucleoside polymerase inhibitor RG7128 and Peg-IFN/RBV combination treatment for up to 12 weeks: interim analysis from the PROPEL study."
About the Phase 2b PROPEL Study
The Phase 2b study enrolled 408 patients with HCV genotypes 1 or 4, cirrhotic and non-cirrhotic, who have not been treated previously. The primary efficacy endpoint of the study is the proportion of patients who achieve an SVR, defined as HCV below the limit of detection (<15 IU/mL as measured by Roche TaqMan assay) 24 weeks after completion of all treatment. The study is being conducted in North America, Europe, and Australia. Patients were enrolled into one of 5 arms:
-- 24 weeks of total treatment; RG7128 500mg BID in combination with SOC for 12 weeks, followed by 12 weeks of SOC ("12+12", RVR guided)
-- 24 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 12 weeks, followed by 12 weeks of SOC ("12+12", RVR guided)
-- 24 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 8 weeks, followed by a further 16 weeks of SOC ("8+16", RVR guided)
-- 48 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 12 weeks, followed by a further 36 weeks of SOC ("12+36", non-RVR guided")
-- A control arm with SOC for 48 weeks. Patients in the 24-week arms will discontinue all treatment at week 24 if they have achieved RVR, defined as HCV RNA below the limit of detection (<15 IU/mL) at week 4 and maintain these low levels of HCV RNA until week 22, a strategy known as "RVR-guided" treatment. Patients who do not meet these criteria will continue on the standard of care until week 48.
RG7128 is also currently being evaluated in a Phase 2b study in which RG7128 and SOC are given for a total of 24 weeks each ("24+0", RVR guided). The regimen will be assessed in treatment-naive HCV-infected patients with genotypes 1 or 4. Enrollment in this study was completed in early May. In addition, Roche anticipates the initiation of another Phase 2 study in HCV-infected patients with genotypes 2 or 3 by the end of 2010.
About Pharmasset Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir(TM) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a cytosine analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV.
These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage HCV candidates include PSI-7977, an unpartnered uracil nucleotide analog that has recently completed a Phase 2a study, and PSI-938 an unpartnered guanine nucleotide analog in Phase 1. We also have in our pipeline an additional purine nucleotide analog, PSI-661, an isomer of PSI-879, in advanced preclinical development. Racivir, for the treatment of HIV, has completed a Phase 2 clinical study.
Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche, Inc.
Contact Richard E. T. Smith, Ph.D. VP, Investor Relations and Corporate Communications Office: +1 (609) 613-4181
Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," including, without limitation, statements that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2009 and our Quarterly Reports on Form 10-Q for the periods ended December 31, 2009 and March 31, 2010 filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.
Source: Pharmasset, Inc.
http://pr-usa.net/index.php?option=com_content&task=view&id=414169&Itemid=33
The PROPEL study is evaluating the dose and duration of treatment of RG7128 in combination with SOC in patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 4 who have not been treated previously. The interim analysis also included on-treatment efficacy data demonstrating that >80% of patients had undetectable HCV RNA in all cohorts receiving the 12-week triple regimen compared to <50% for the placebo/SOC cohort. The safety and efficacy results from the interim analysis of the PROPEL Phase 2b study of RG7128 have been submitted by Roche as an abstract to AASLD for the Annual Liver Meeting (October 29 to November 2, 2010).
The title of the abstract is:
"High rates of early viral response, promising safety profile and lack of resistance-related breakthrough in HCV GT 1/4 patients treated with RG7128 plus PegIFN alfa-2a (40KD)/RBV: Planned Week 12 interim analysis from the PROPEL study"
"We are encouraged by the reported efficacy, safety, and resistance data from this interim analysis of the PROPEL study," said M. Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We believe safety, absence of resistance, as well as antiviral potency will all be important considerations as HCV treatment incorporates direct acting antivirals in combination with interferon, and in potential interferon-free antiviral combination regimens."
No viral rebounds or resistance-related breakthroughs were noted during the first 8 or 12 weeks of triple combination therapy, consistent with the demonstrated high barrier to resistance in earlier RG7128 clinical studies. In clinical reports to date, the S282T mutation associated with RG7128 resistance in vitro has not been detected at baseline in HCV-infected patients enrolling in clinical trials. A separate abstract has been submitted by Roche including details of the resistance analyses that have been conducted during this study, including sequencing of the HCV RNA from all patients at baseline. The abstract is entitled:
"No evidence of drug resistance or baseline S282T resistance mutation among GT1 and GT4 HCV infected patients on nucleoside polymerase inhibitor RG7128 and Peg-IFN/RBV combination treatment for up to 12 weeks: interim analysis from the PROPEL study."
About the Phase 2b PROPEL Study
The Phase 2b study enrolled 408 patients with HCV genotypes 1 or 4, cirrhotic and non-cirrhotic, who have not been treated previously. The primary efficacy endpoint of the study is the proportion of patients who achieve an SVR, defined as HCV below the limit of detection (<15 IU/mL as measured by Roche TaqMan assay) 24 weeks after completion of all treatment. The study is being conducted in North America, Europe, and Australia. Patients were enrolled into one of 5 arms:
-- 24 weeks of total treatment; RG7128 500mg BID in combination with SOC for 12 weeks, followed by 12 weeks of SOC ("12+12", RVR guided)
-- 24 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 12 weeks, followed by 12 weeks of SOC ("12+12", RVR guided)
-- 24 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 8 weeks, followed by a further 16 weeks of SOC ("8+16", RVR guided)
-- 48 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 12 weeks, followed by a further 36 weeks of SOC ("12+36", non-RVR guided")
-- A control arm with SOC for 48 weeks. Patients in the 24-week arms will discontinue all treatment at week 24 if they have achieved RVR, defined as HCV RNA below the limit of detection (<15 IU/mL) at week 4 and maintain these low levels of HCV RNA until week 22, a strategy known as "RVR-guided" treatment. Patients who do not meet these criteria will continue on the standard of care until week 48.
RG7128 is also currently being evaluated in a Phase 2b study in which RG7128 and SOC are given for a total of 24 weeks each ("24+0", RVR guided). The regimen will be assessed in treatment-naive HCV-infected patients with genotypes 1 or 4. Enrollment in this study was completed in early May. In addition, Roche anticipates the initiation of another Phase 2 study in HCV-infected patients with genotypes 2 or 3 by the end of 2010.
About Pharmasset Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir(TM) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a cytosine analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV.
These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage HCV candidates include PSI-7977, an unpartnered uracil nucleotide analog that has recently completed a Phase 2a study, and PSI-938 an unpartnered guanine nucleotide analog in Phase 1. We also have in our pipeline an additional purine nucleotide analog, PSI-661, an isomer of PSI-879, in advanced preclinical development. Racivir, for the treatment of HIV, has completed a Phase 2 clinical study.
Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche, Inc.
Contact Richard E. T. Smith, Ph.D. VP, Investor Relations and Corporate Communications Office: +1 (609) 613-4181
Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," including, without limitation, statements that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2009 and our Quarterly Reports on Form 10-Q for the periods ended December 31, 2009 and March 31, 2010 filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.
Source: Pharmasset, Inc.
http://pr-usa.net/index.php?option=com_content&task=view&id=414169&Itemid=33
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